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Author Topic: Aorta  (Read 790 times)
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dennis100
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« on: May 16, 2018, 03:15:50 AM »

Model Number 102
Event Date 09/10/2013
Event Type  Injury   
Event Description
It was reported that the patient has been experiencing episodes of bradycardia over the past month which has progressively worsened since then. It was reported that the patient was seen in the emergency room a month ago and that the hospital informed the patient that there is a leak around his aorta, but they do not think that is the cause of the entire problem. The relationship of the bradycardia to vns therapy is unknown. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3459716
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dennis100
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« Reply #1 on: May 16, 2018, 03:16:39 AM »

Model Number 102
Event Date 06/04/2012
Event Type  Death   
Manufacturer Narrative
Analysis of programming history performed.
 
Event Description
On (b)(6) 2013 a sudep evaluation was performed by the manufacturer with the information available and it was determined that the patient¿s death is considered to be possibly sudep related.
 
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was: atherosclerotic heart disease; benign neoplasm of adrenal gland; myocardial degeneration; cardiomegaly; atherosclerosis of aorta. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported that the patient had not been seen in a long time, and the treating physician was unknown. The company case manager searched online and found an obituary for the patient who passed away on (b)(6) 2012. The reason is unknown. The patient¿s previously treating physician moved a few years prior and no longer practices vns. The patient passed away outside of his care. Review of the company programming history database revealed the patient¿s last programming physician was another physician (on (b)(6) 2010). Attempts for additional information from this physician have been unsuccessful to date.
 
Event Description
Follow-up with the funeral home was done and they did not have the generator or lead for return.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3205872
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dennis100
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« Reply #2 on: May 18, 2018, 07:02:30 AM »

Model Number 103
Event Date 01/07/2013
Event Type  Death   
Manufacturer Narrative

Event Description
On (b)(6) 2013, the patient was admitted to the hospital for implantation of the device. Pre-surgical clinical findings included patient complaint of mild chest pain with dyspnea, left shoulder pain, and right lower limb pain and numbness. The patient underwent general anesthesia and implantation of a left vns therapy system on (b)(6) 2013 with model 103 generator serial number (b)(4) and model 304-20 serial number (b)(4) on the left vagal nerve. Per the operative notes, the patient's neck vessels were severely engorged, but there was reportedly no severe bleeding during surgery. (of note, the patient was on anti-platelet medications which inhibit thrombus formation). Two normal mode diagnostic tests were performed intra-operatively per labeling which were within normal limits. The vns system was not programmed on, that is there was no stimulation, at any other time during or after the implantation procedure of (b)(6) 2013. After completing the operation on (b)(6) 2013, the patient did not regain consciousness and was found to have lateralizing neurological signs. An initial ct scan of the head on (b)(6) 2013 revealed a non-hemorrhagic left fronto-tempero-parietal-occipital infarction and evidence of intra-cerebral swelling. The patient was treated with anti-edema measures and pulmonary ventilation was continued post-operatively. Treatment included iv drugs piracetam, mannitol, citicoline. However, the patient's neurological condition deteriorated. A second ct scan of the head on (b)(6) 2013 revealed hemorrhagic transformation of the large infarct. In response to this event, the patient underwent neurosurgery for decompression craniotomy of intra-cerebral swelling. As of (b)(6) 2013, the patient was placed on a ventilator and was haemodynamically stable with worsening renal functioning. The patient was appropriately managed by intensivists, neurologists, neurosurgeon, and cardiologist. In spite of the efforts, the patient was declared expired and was removed from the ventilator on (b)(6) 2013. Per the death certificate, the cause of death was acute left internal carotid artery infarct with haemorrhagic transformation with cerebral edema and dilated cardiomyopathy, acute respiratory failure, peripheral vascular disease, tricuspid heart dysplasia, old anterior wall myocardial infarction leading to cardio-respiratory arrest. In the opinion of the investigator, the relation of the death to the implant procedure was determined to be probable; however, there were clinical factors that likely contributed to the death. The patient had significant coronary and peripheral vascular disease that consisted of severe, three-vessel coronary artery disease and severely impaired left ventricular systolic function, carotid atherosclerosis, bilateral claudication with total infra-renal occlusion of the aorta. The patient also had pre-existing severe mitral regurgitation. The overall impression of the clinical event adjudication committee was that the patient was severely compromised as a result, with risks factors for general anesthesia complications that included previous myocardial infarction, severe ischemic cardiomyopathy, ongoing heart failure, severe mitral insufficiency, total aortic occlusion, and renal insufficiency, and risk factors for thromboembolism that included severely compromised left ventricular function including left ventricular dyskinesis, mitral insufficiency, carotid atherosclerosis, and renal insufficiency. The death is not believed to be related to vns stimulation, as the device was not turned on following implant. Implantation surgery has known potential risks, complications, and side effects identified in both the investigator's brochure and the device labeling. The generator was explanted on (b)(6) 2013. Product return to the manufacturer is expected, but the generator has not been received to date. The lead was not explanted prior to the patient's cremation.
 
Event Description
It was reported that the patient had prolonged hospitalization.
 
Manufacturer Narrative
Describe event or problem: patient (b)(6) male was enrolled in (b)(4), a randomized, multi-site, open-label feasibility study designed to collect data on patients with stable symptomatic heart failure ((b)(6) functional classification class ii/iii) implanted with the model 103 and model 304 vns therapy system from baseline through 34 weeks post-baseline. The clinical trial is being conducted in (b)(6) and has been approved by (b)(6). The vns therapy products used are the same products used in commercial distribution. The patient was randomized to cervical vns implantation on the left vagal nerve. Common device name: product code nke (congestive heart failure) is an unapproved indication.
 
Event Description
The explanted generator was receieved by the manufacturer for analysis. However, product analysis has not been completed to date. The return product form indicated the device was returned due to 'acute ica left infarct with heamorrhagic transformation with cerebral edema leading to death. ' explant date was also listed as (b)(6) 2013.
 
Event Description
Product analysis was completed on the explanted generator. The returned model 103 generator performed within all specifications during electrical testing. There were no adverse functional, mechanical, or visual issues identified with the generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to manufacturer functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2939332
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dennis100
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« Reply #3 on: May 22, 2018, 02:46:38 AM »

Model Number 102
Event Date 11/20/2011
Event Type  Death   
Event Description
Additional information was received on (b)(4) 2013 when the physician reported that there is no relationship between the cardiopulmonary arrest, atrial fibrillation, and congestive heart failure to vns. The events did not occur with stimulation. No causal or contributory programming or medication changes preceded the onset of these events. The physician stated that he believes the patient had a pre-vns medical history of atrial fibrillation and congestive heart failure. The patient had a previous risk factor of "l/v smoking and hypertension" which may have predisposed the patient to myocardial infarctions according to the physician.
 
Event Description
Additional information is received on (b)(4) 2013 when the physician reported that it is unknown when the patient passed away and the relationship of the patient's death to vns. A copy of the patient's death certificate was requested from the department of vital records in the state the patient passed away in but it has not been received to date.
 
Event Description
On (b)(6) 2012, it was reported that the vns patient has passed away on (b)(6) 2011. Additional information has been requested from the patient's physician but no further information has been received to date. Based on the information received to date, the patient's death is possibly sudep at this time.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2013 when the patient's death certificate was received. The patient passed away on (b)(6) 2011 and the immediate cause of death was noted to be cardiopulmonary arrest, congestive heart failure, atrial fibrillation, and aortic stenosis. The approximate interval between the onset of these events and death was minutes for the cardiopulmonary arrest and years for the congestive heart failure, atrial fibrillation, and aortic stenosis. An autopsy was not performed and the manner of death was stated to be "natural". Good faith attempts for further information from the physician have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2892949
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dennis100
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« Reply #4 on: May 22, 2018, 02:47:34 AM »

Model Number 102
Event Date 12/15/2006
Event Type  Death   
Event Description
All attempts to the reporter for additional information have been unsuccessful to date. Follow up with the vital records office revealed the cause of death was cardiopulmonary arrest and aortic thrombosis. No autopsy was performed. Follow up with the funeral home revealed the patient was cremated, and the vns was explanted and discarded.
 
Manufacturer Narrative

Event Description
Reporter indicated a vns patient had died on (b)(6) 2006. No information regarding the death or the relationship of the death to the vns was provided. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2687342
« Last Edit: July 23, 2018, 04:09:56 AM by dennis100 » Logged
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