PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2010-00395
- Event Type
- Death
- Date Received
- May 21, 2010
- Date of Event
- June 11, 2009
- Report Date
- October 1, 2010
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER
Narratives
INFORMATION WAS RECEIVED VIA THE (B) (4) STUDY THAT TWO MONTHS POST IMPLANTATION OF A PRECISE STENT TO TREAT A RIGHT PROXIMAL INTERNAL CAROTID ARTERY STENOSIS THE PATIENT EXPERIENCED DYSARTHRIA AND AMAUROSIS FUGAX DIAGNOSED AS AN ISCHEMIC STROKE. NO ADDITIONAL TREATMENT WAS NECESSARY AND THE PATIENT MADE A FULL RECOVERY. IT WAS INDICATED THAT THIS EVENT WAS UNRELATED TO THE DEVICE AND UNRELATED TO THE PROCEDURE. INFORMATION WAS RECEIVED THAT THERE WAS DOCUMENTATION THAT THE PATIENT'S RIGHT HEMISPHERIC INFARCTION WAS MOST LIKELY CARDIOEMBOLIC IN NATURE. ADDITIONAL INFORMATION REPORTED THAT APPROXIMATELY 21 WEEKS POST INDEX PROCEDURE, THE PATIENT DIED; INDICATED AS UNRELATED TO THE DEVICE AND UNRELATED TO THE PROCEDURE. THE CAUSE OF DEATH WAS LISTED AS CEREBROVASCULAR ACCIDENT AND CARDIAC ARRHYTHMIA ON THE DEATH CERTIFICATE. IT WAS REPORTED THAT THE PATIENT HAD A STROKE AND WENT HOME UNDER HOSPICE CARE AND DIED AT HOME. ATHEROSCLEROTIC HEART DISEASE IS ALSO LISTED AS A SIGNIFICANT CONDITION CONTRIBUTING TO THE DEATH BUT NOT RESULTING IN THE UNDERLYING CAUSE. THERE IS NO FURTHER INFORMATION REGARDING THE SPECIFICS OF THIS EVENT. THE PATIENT HAD A STROKE EIGHT YEARS PRIOR TO INDEX STENT PLACEMENT PROCEDURE. PRE INDEX PROCEDURE SYMPTOMS INCLUDED LEFT HAND PARAESTHESIA AND NUMBNESS ALONG WITH GAIT DISTURBANCE WHICH HAD RESOLVED. IN ADDITION, PRE-PROCEDURE MRI SHOWED ISCHEMIA IN THE RIGHT MIDDLE CEREBRAL ARTERY DISTRIBUTION AND ACUTE RIGHT ISCHEMIC PARIETAL CHANGES. ADDITIONAL MEDICAL HISTORY INCLUDED HYPERTENSION, HYPERLIPIDEMIA, CORONARY ARTERY DISEASE 3 YEARS STATUS POST CARDIAC STENT PLACEMENT, AND DIABETES MELLITUS. ECG SHOWED SINUS BRADYCARDIA WITH 1ST DEGREE AV BLOCK WITH REPORTED FAIRLY REGULAR EPISODES OF ANGINA MOSTLY RELATED TO EXERTION SUCH AS WALKING SUBSIDING WITH REST. CAROTID ENDARTERECTOMY WAS INITIALLY SCHEDULED, HOWEVER DUE TO CAROTID ARTERY STENOSIS AS WELL AS HIGH INTRACRANIAL CAROTID ARTERY STENOSIS, IT WAS CANCELED. INFORMATION SPECIFIC TO THE CAROTID ARTERY STENTING PROCEDURE REPORTED PRE-PROCEDURE NIH SCORE WAS 0. THERE WAS A 94% STENOSIS WITH A LESION LENGTH OF 30.88 WITH NO THROMBOSIS. THE LESION WAS CIRCUMFERENTIAL, ECCENTRIC WITH MILD CALCIFICATION. THE REFERENCE DIAMETER WAS 4.55MM AND ARCH TYPE I WAS DOCUMENTED. A 6MM ANGIOGUARD RX WAS DEPLOYED AND RETRIEVED SUCCESSFULLY WITHOUT ADVERSE EVENT OR MALFUNCTION. THE VESSEL WAS PREDILATED WITH DOCUMENTED RESISTANCE OR DISSECTION. THE 7 X 30 PRECISE STENT WAS DEPLOYED AT THE TARGET LESION WITH NO MALFUNCTION OR ASSOCIATED MAJOR ADVERSE EVENT. THE TOTAL LENGTH OF THE STENTED SEGMENT WAS 30MM. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICITS. THE PATIENT WAS DISCHARGED THE NEXT DAY. THE PATIENT¿S POST PROCEDURE ANTI-PLATELET REGIMEN INCLUDED ASPIRIN AND CLOPIDOGREL. AT 30 DAY FOLLOW-UP, IT WAS DOCUMENTED THAT THERE WERE NO ADVERSE EVENTS AND THE (B) (6) STROKE SCORE WAS 0. THE STENT REMAINS IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 14038660 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. STROKE AND DEATH ARE WELL-KNOWN DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU AS SUCH. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE THE PATIENT¿S EXTENSIVE PRE-EXISTING MEDICAL CONDITION INCLUDING CEREBRAL AND CARDIOVASCULAR DISEASE AND DIABETES MELLITUS, PROCEDURAL, STENT TO LESION SIZING, LESION CHARACTERISTICS, AND PHARMACOLOGICAL FACTORS. BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE PRECISE STENT TO THE EVENTS. HOWEVER, THERE IS NO INDICATION THAT IT IS RELATED TO THE DEVICE MANUFACTURING PROCESS
THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
ADJUDICATION MINUTES REVIEW. PLEASE NOTE THAT THE ADJUDICATION MINUTES AS RECEIVED USE THE YEARS 2009 AND 2010 INTERCHANGEABLY THROUGHOUT THE REPORT. WE WILL ASSUME ALL DATES ARE 2009. THE ADJUDICATION MINUTES RECEIVED 9/3/2010 AGREED WITH THE PREVIOUSLY REPORTED DIAGNOSES OF AN ISCHEMIC STROKE AND APPROXIMATELY 4 MONTHS AFTER THE INDEX PROCEDURE A CVA RESULTING IN THE PATIENT'S DEATH. THE DEATH CERTIFICATE DOCUMENTED THE IMMEDIATE CAUSE OF DEATH AS CEREBROVASCULAR ACCIDENT DUE TO OR AS A CONSEQUENCE OF CARDIAC ARRHYTHMIA. NO AUTOPSY WAS PERFORMED. THIS INFORMATION DOES NOT CHANGE THE PREVIOUS DETERMINATION. ON (B)(6)2009, APPROXIMATELY 2 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT NOTED SOME NUMBNESS AND CLUMSINESS AFFECTING HIS LEFT UPPER EXTREMITY. HE PRESENTED TO THE EMERGENCY ROOM WHERE HE COMPLAINED OF PROGRESSIVE SHORTNESS OF BREATH AND GENERALIZED WEAKNESS BUT DENIED CHEST PAIN. ON FURTHER WORK-UP HE HAD BILATERAL PLEURAL EFFUSIONS AND ATRIAL FIBRILLATION WITH A SLOW VENTRICULAR RESPONSE. ON (B)(6)2009 AN MRI AND CT WERE PERFORMED CONFIRMING AN ACUTE RIGHT SIDED INFARCT. (THIS EVENT HAD BEEN CAPTURED). IN ADDITION, ON (B)(6)2009 A CAROTID DUPLEX SCAN REVEALED A PATENT RIGHT CAROTID ARTERY STENT WITH NO EVIDENCE OF STENOSIS. THE PATIENT WAS TRANSFERRED TO A STROKE REHABILITATION CENTER ON (B)(6)2009. ON (B)(6)2009, A HEAD CT WITHOUT CONTRAST REVEALED NEW RIGHT TEMPORAL LOBE INFARCTION THAT WAS NOT SEEN ON HIS INITIAL INFARCTION SUGGESTING THAT HE MAY HAVE EXTENDED HIS DEFICIT ON THE RIGHT HEMISPHERE. ON (B)(6)2009, THE PATIENT AGAIN PRESENTED TO THE EMERGENCY ROOM. CT REVEALED POSSIBLE SUBACUTE INFARCTIONS WITH NO EVIDENCE OF ACUTE HEMORRHAGE. CLINICAL CORRELATION WITH AN MRI WAS RECOMMENDED. THE PATIENT WAS DISCHARGED TO HOME WITH HOSPICE CARE ON OR AROUND (B)(6)2009. ON (B)(6)2009, THE PATIENT EXPIRED. THE SITE REPORTED THE CAUSE OF DEATH AS NEUROLOGICAL. THE DEATH CERTIFICATE DOCUMENTED THE IMMEDIATE CAUSE OF DEATH AS CEREBROVASCULAR ACCIDENT DUE TO OR AS A CONSEQUENCE OF CARDIAC ARRHYTHMIA. NO AUTOPSY WAS PERFORMED. ORIGINALLY THE STROKE DATED (B)(6)2009 WAS MADE NON-REPORTABLE AS INFORMATION PROVIDED NOTED THAT NO ADDITIONAL TREATMENT WAS NECESSARY AND THE PATIENT MADE A FULL RECOVERY. HOWEVER, NEW INFORMATION NOTES THAT THE PATIENT DID HAVE SOME RESIDUAL INJURY AND WAS TRANSFERRED TO A REHAB FACILITY. THIS EVENT WILL BE MADE A REPORTABLE EVENT. ADDITIONALLY, THE MINUTES PROVIDE FOR STROKES OCCURRING ON (B)(6)2009. PER THE MINUTES, IT WAS NOTED THAT THE STROKE REPORTED (B)(6)2009 WAS AN EXTENSION OF THE ORIGINAL INFARCT OCCURRING 6/11/2009. AS SUCH IT WILL NOT BE ADDED AS A SEPARATE EVENT. THE STROKE REPORTED (B)(6)2009 WILL BE ADDED AS A REPORTABLE COMPLAINT AS TREATMENT AND DURATION ARE UNKNOWN. THE STROKE REPORTED (B)(6)2009 HAS PREVIOUSLY BEEN CAPTURED AS A REPORTABLE COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
INFORMATION WAS RECEIVED VIA THE (B)(4) STUDY AND THE ADJUDICATION PROCESS THAT POST RIGHT CAROTID PRECISE STENTING, THE PATIENT HAD MULTIPLE STROKES TWO AND THREE MONTHS POST INDEX PROCEDURE. THE PATIENT SUBSEQUENTLY DIED APPROXIMATELY 21 WEEKS POST PROCEDURE. INITIALLY, IT WAS REPORTED THAT TWO MONTHS POST IMPLANTATION OF A PRECISE STENT TO TREAT A RIGHT PROXIMAL INTERNAL CAROTID ARTERY STENOSIS THE PATIENT EXPERIENCED DYSARTHRIA AND AMAUROSIS FUGAX DIAGNOSED AS AN ISCHEMIC STROKE. NO ADDITIONAL TREATMENT WAS NECESSARY AND THE PATIENT MADE A FULL RECOVERY. IT WAS INDICATED THAT THIS EVENT WAS UNRELATED TO THE DEVICE AND UNRELATED TO THE PROCEDURE. INFORMATION WAS RECEIVED THAT THERE WAS DOCUMENTATION THAT THE PATIENT'S RIGHT HEMISPHERIC INFARCTION WAS MOST LIKELY CARDIOEMBOLIC IN NATURE. ADDITIONAL INFORMATION RECEIVED VIA THE ADJUDICATION PROCESS REPORTED THAT THE PATIENT NOTED SOME NUMBNESS AND CLUMSINESS AFFECTING HIS LEFT UPPER EXTREMITY. HE PRESENTED TO THE EMERGENCY ROOM WHERE HE COMPLAINED OF PROGRESSIVE SHORTNESS OF BREATH AND GENERALIZED WEAKNESS BUT DENIED CHEST PAIN. ON FURTHER WORK-UP, HE HAD BILATERAL PLEURAL EFFUSIONS AND ATRIAL FIBRILLATION WITH A SLOW VENTRICULAR RESPONSE. IT WAS ALSO REPORTED THE PATIENT DID HAVE SOME RESIDUAL INJURY AND WAS TRANSFERRED TO A REHAB FACILITY. APPROXIMATELY 2 WEEKS LATER, A HEAD CT WITHOUT CONTRAST REVEALED NEW RIGHT TEMPORAL LOBE INFARCTION THAT WAS NOT SEEN ON HIS INITIAL INFARCTION SUGGESTING THAT HE MAY HAVE EXTENDED HIS DEFICIT ON THE RIGHT HEMISPHERE. THE PATIENT AGAIN PRESENTED TO THE ONE WEEK LATER AND CT REVEALED POSSIBLE SUBACUTE INFARCTIONS WITH NO EVIDENCE OF ACUTE HEMORRHAGE. CLINICAL CORRELATION WITH AN MRI WAS RECOMMENDED. THE PATIENT WAS DISCHARGED TO HOME WITH HOSPICE CARE APPROXIMATELY THREE DAYS LATER. APPROXIMATELY 21 WEEKS POST INDEX PROCEDURE, THE PATIENT DIED; INDICATED AS UNRELATED TO THE DEVICE AND UNRELATED TO THE PROCEDURE. THE CAUSE OF DEATH WAS LISTED AS CEREBROVASCULAR ACCIDENT AND CARDIAC ARRHYTHMIA ON THE DEATH CERTIFICATE. ATHEROSCLEROTIC HEART DISEASE IS ALSO LISTED AS A SIGNIFICANT CONDITION CONTRIBUTING TO THE DEATH BUT NOT RESULTING IN THE UNDERLYING CAUSE. NO AUTOPSY WAS PERFORMED. THE PATIENT HAD A STROKE EIGHT YEARS PRIOR TO INDEX STENT PLACEMENT PROCEDURE. PRE INDEX PROCEDURE SYMPTOMS INCLUDED LEFT HAND PARAESTHESIA AND NUMBNESS ALONG WITH GAIT DISTURBANCE WHICH HAD RESOLVED. IN ADDITION, PRE-PROCEDURE MRI SHOWED ISCHEMIA IN THE RIGHT MIDDLE CEREBRAL ARTERY DISTRIBUTION AND ACUTE RIGHT ISCHEMIC PARIETAL CHANGES. ADDITIONAL MEDICAL HISTORY INCLUDED HYPERTENSION, HYPERLIPIDEMIA, CORONARY ARTERY DISEASE 3 YEARS STATUS POST CARDIAC STENT PLACEMENT, AND DIABETES MELLITUS. ECG SHOWED SINUS BRADYCARDIA WITH 1ST DEGREE AV BLOCK WITH REPORTED FAIRLY REGULAR EPISODES OF ANGINA MOSTLY RELATED TO EXERTION SUCH AS WALKING SUBSIDING WITH REST. CAROTID ENDARTERECTOMY WAS INITIALLY SCHEDULED, HOWEVER DUE TO CAROTID ARTERY STENOSIS AS WELL AS HIGH INTRACRANIAL CAROTID ARTERY STENOSIS, IT WAS CANCELED. INFORMATION SPECIFIC TO THE CAROTID ARTERY STENTING PROCEDURE REPORTED PRE-PROCEDURE (B)(6) SCORE WAS 0. THERE WAS A 94% STENOSIS WITH A LESION LENGTH OF 30.88 WITH NO THROMBOSIS. THE LESION WAS CIRCUMFERENTIAL, ECCENTRIC WITH MILD CALCIFICATION. THE REFERENCE DIAMETER WAS 4.55MM AND ARCH TYPE I WAS DOCUMENTED. A 6MM ANGIOGUARD RX WAS DEPLOYED AND RETRIEVED SUCCESSFULLY WITHOUT ADVERSE EVENT OR MALFUNCTION. THE VESSEL WAS PREDILATED WITH DOCUMENTED RESISTANCE OR DISSECTION. THE 7 X 30 PRECISE STENT WAS DEPLOYED AT THE TARGET LESION WITH NO MALFUNCTION OR ASSOCIATED MAJOR ADVERSE EVENT. THE TOTAL LENGTH OF THE STENTED SEGMENT WAS 30MM. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICITS. THE PATIENT WAS DISCHARGED THE NEXT DAY. THE PATIENT'S POST PROCEDURE ANTI-PLATELET REGIMEN INCLUDED ASPIRIN AND CLOPIDOGREL. AT 30 DAY FOLLOW-UP, IT WAS DOCUMENTED THAT THERE WERE NO ADVERSE EVENTS AND THE (B)(6) STROKE SCORE WAS 0. THE STENT REMAINS IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 14038660 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. STROKE AND DEATH ARE WELL-KNOWN DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU AS SUCH. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE THE PATIENT'S EXTENSIVE PRE-EXISTING MEDICAL CONDITION INCLUDING CEREBRAL AND CARDIOVASCULAR DISEASE AND DIABETES MELLITUS, PROCEDURAL, STENT TO LESION SIZING, LESION CHARACTERISTICS, AND PHARMACOLOGICAL FACTORS. BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE PRECISE STENT TO THE EVENTS. HOWEVER, THERE IS NO INDICATION THAT IT IS RELATED TO THE DEVICE PERFORMANCE OR MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
IN A LITERATURE REVIEW TITLED "COMPARISON OF VERTEBROPLASTY AND BALLOON KYPHOPLASTY FOR TREATMENT OF VERTEBRAL COMPRESSION FRACTURES: A META-ANALYSIS OF THE LITERATURE", THE FOLLOWING EVENT WAS REPORTED: ONE PATIENT WITH A WOUND INFECTION REQUIRING SURGICAL DEBRIDEMENT, IRRIGATION AND CLOSURE THREE WEEKS POST KYPHOPLASTY AND DECOMPRESSIVE SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.
IT WAS REPORTED IN A SERVICE REPORT THAT THE STRETCHER'S LEFT SIDERAIL WOULD NOT LATCH. NO ADVERSE CONSEQUENCES REPORTED.
AS IT WAS REPORTED BY THE (B) (4) STUDY DATABASE: THE PATIENT RECEIVED A PRECISE STENT IN THE PROXIMAL INTERNAL CAROTID ARTERY. APPROXIMATELY 2 MONTHS POST PROCEDURE, THE PATIENT EXPERIENCED DYSARTHRIA AND AMAUROSIS FUGAX DIAGNOSED AS AN ISCHEMIC STROKE. NO ADDITIONAL TREATMENT WAS NECESSARY AND THE PATIENT MADE A FULL RECOVERY. OVER FOUR MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DIED. AFTER THE PREVIOUSLY REPORTED STROKE, THE PATIENT WENT HOME UNDER HOSPICE CARE AND THEN PASSED AWAY AT HOME. THE DEATH CERTIFICATE FOR THE PATIENT LISTS CAUSE OF DEATH AS: CEREBROVASCULAR ACCIDENT AND CARDIAC ARRYTHMIA. ALSO LISTED AS A "SIGNIFICANT CONDITION CONTRIBUTING TO DEATH, BUT NOT RESULTING IN THE UNDERLYING CAUSE" IS ATHEROSCLEROTIC HEART DISEASE. THE PATIENT HAD A PRIOR HISTORY OF CARDIAC ISSUES.
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE DISPLAYED DIFFERENT REMAINING LONGEVITY INDICATORS WITHIN A FEW MINUTES. THE INITIAL INDICATOR REVEALED NEAR ELECTIVE REPLACEMENT INDICATORS SUGGESTING A THREE MONTH FOLLOW UP. AFTER THE PACING AND SENSING INTERROGATION, THE DEVICE DISPLAYED INDICATORS CLOSE TO ELECTIVE REPLACEMENT TIME. NO ADVERSE PATIENT EFFECTS WERE CONTACTED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING THE DISCREPANCY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISE PRO RX CAROTID STENT SYSTEM | SELF EXPANDING STENTS (NIM) | NIM | CORDIS DE MEXICO | NA | 14038660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Death | ASPIRIN, CLOPIDOGREL |