PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2012-00702
- Event Type
- Injury
- Date Received
- November 29, 2012
- Date of Event
- October 29, 2012
- Report Date
- November 5, 2012
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
AS REPORTED VIA THE (B)(6) REGISTRY, A PATIENT EXPERIENCED AN ISCHEMIC STROKE FIVE DAYS AFTER THE INDEX PROCEDURE. AT THE TIME OF THE PROCEDURE, ANGIOGRAPHY REVEALED 95% STENOSIS IN THE PROXIMAL AND OSTIAL RIGHT INTERNAL CAROTID ARTERY. PRE-PROCEDURE NIH STROKE SCALE SCORE WAS 0 AND THE PATIENT WAS ASYMPTOMATIC. THE LESION WAS DESCRIBED AS 10MM IN LENGTH, SEVERELY CALCIFIED, AORTIC ARCH TYPE I AND ECCENTRIC LESION. THE REFERENCE VESSEL WAS 5.5MM IN DIAMETER WITH MILD TORTUOUSITY. A 7MM ANGIOGUARD WAS DEPLOYED BEYOND THE TARGET LESION WHICH WAS PRE-DILATED AND FOLLOWED BY DEPLOYMENT OF AN 8.0 X 30MM PRECISE PRO STENT. NO NEUROLOGICAL DEFICITS WERE REPORTED WHEN THE PATIENT LEFT THE ANGIOGRAPHY SUITE. IT WAS NOTED, THAT THERE WAS OCCLUSION IN THE CONTRALATERAL CAROTID ARTERY. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH A NIH STROKE SCALE SCORE OF 0; THE RANKIN STROKE SCALE WAS NOT PERFORMED AT THIS TIME. CLOPIDOGREL WAS ADMINISTERED AT PRE, POST AND DISCHARGE. FIVE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH GAIT INSTABILITY AND LEFT SIDE WEAKNESS. MRI INDICATED RIGHT MIDDLE CEREBRAL ARTERY, LEFT MIDDLE CEREBRAL ARTERY AND RIGHT PROXIMAL CEREBRAL ARTERY CVA SECONDARY TO AN EMBOLIC EVENT. THE PATIENT WAS TREATED WITH HEPARIN DRIP AND COUMADIN WAS STARTED, AS WELL AS BEING FOLLOWED BY PHYSICAL THERAPY. HE WAS TRANSFERRED TO THE ACUTE INPATIENT REHAB WHERE HE IS RECEIVING PHYSICAL THERAPY AND FULLY COOPERATING. THE PATIENT HAS A KNOWN MEDICAL HISTORY OF CONTRALATERAL CAROTID OCCLUSION (100%) AND BILATERAL ARTERY STENOSIS AS DETERMINED BY ANGIOGRAPHY IN WHICH BOTH CAROTID ARTERIES REQUIRE TREATMENT. PER THE INVESTIGATOR, THE EVENT WAS RELATED TO THE STUDY STENT WHICH WAS FOUND TO BE COMPLETELY OCCLUDED DURING CAROTID DUPLEX. PER THE SITE, THERE IS NO SPECIFICATION ON WHAT OCCLUDED THE STENT. 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 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. CEREBROVASCULAR ACCIDENT IS A WELL DOCUMENTED POTENTIAL COMPLICATION OF CAROTID ARTERY INTERVENTIONS AND IS LISTED IN THE IFU AS SUCH. EMBOLIC STROKES ARE USUALLY CAUSED BY AN EMBOLUS (A BLOOD CLOT THAT FORMS ELSEWHERE IN THE BODY AND TRAVELS THROUGH THE BLOODSTREAM TO THE BRAIN) THAT TRAVELS FROM OTHER PARTS OF THE BODY TO THE NECK OR BRAIN AND BLOCKS A BLOOD VESSEL. EMBOLIC STROKES OFTEN RESULT FROM HEART DISEASE OR HEART SURGERY AND OCCUR RAPIDLY AND WITHOUT ANY WARNING SIGNS. ABOUT 15 PERCENT OF EMBOLIC STROKES OCCUR IN PEOPLE WITH ATRIAL FIBRILLATION. WHEN A CLOT FORMS IN A BLOOD VESSEL IN THE BRAIN OR NECK IT IS CALLED A THROMBOTIC STROKE. EMBOLIC AND THROMBOTIC STROKES ARE CATEGORIZED AS ISCHEMIC STROKE. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, PHARMACEUTICAL, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. ISR IS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.
ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
COMPLAINT CONCLUSION UPDATED: THE SAPPHIRE STUDY FILE WAS ADJUDICATED. PER THE CEC COMMITTEE, THE PATIENT EXPERIENCED AN ACUTE STENT THROMBOSIS WITHIN THE FIRST 24 HOURS POST PROCEDURE. PER THE COMMITTEE, THE EVENT WAS RELATED TO THE INDEX PROCEDURE AND RELATED TO THE STUDY DEVICE. AS REPORTED VIA THE SAPPHIRE REGISTRY, A PATIENT EXPERIENCED AN ISCHEMIC STROKE FIVE DAYS AFTER THE INDEX PROCEDURE. AT THE TIME OF THE PROCEDURE, ANGIOGRAPHY REVEALED 95% STENOSIS IN THE PROXIMAL AND OSTIAL RIGHT INTERNAL CAROTID ARTERY. PRE-PROCEDURE NIH STROKE SCALE SCORE WAS 0 AND THE PATIENT WAS ASYMPTOMATIC. THE LESION WAS DESCRIBED AS 10MM IN LENGTH, SEVERELY CALCIFIED, AORTIC ARCH TYPE I AND ECCENTRIC LESION. THE REFERENCE VESSEL WAS 5.5MM IN DIAMETER WITH MILD TORTUOUSITY. A 7MM ANGIOGUARD WAS DEPLOYED BEYOND THE TARGET LESION WHICH WAS PRE-DILATED AND FOLLOWED BY DEPLOYMENT OF AN 8.0 X 30MM PRECISE PRO STENT. NO NEUROLOGICAL DEFICITS WERE REPORTED WHEN THE PATIENT LEFT THE ANGIOGRAPHY SUITE. IT WAS NOTED, THAT THERE WAS OCCLUSION IN THE CONTRALATERAL CAROTID ARTERY. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH A NIH STROKE SCALE SCORE OF 0; THE RANKIN STROKE SCALE WAS NOT PERFORMED AT THIS TIME. CLOPIDOGREL WAS ADMINISTERED AT PRE, POST AND DISCHARGE. FIVE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH GAIT INSTABILITY AND LEFT SIDE WEAKNESS. MRI INDICATED RIGHT MIDDLE CEREBRAL ARTERY, LEFT MIDDLE CEREBRAL ARTERY AND RIGHT PROXIMAL CEREBRAL ARTERY CVA SECONDARY TO AN EMBOLIC EVENT. THE PATIENT WAS TREATED WITH HEPARIN DRIP AND COUMADIN WAS STARTED, AS WELL AS BEING FOLLOWED BY PHYSICAL THERAPY. HE WAS TRANSFERRED TO THE ACUTE INPATIENT REHAB WHERE HE IS RECEIVING PHYSICAL THERAPY AND FULLY COOPERATING. THE PATIENT HAS A KNOWN MEDICAL HISTORY OF CONTRALATERAL CAROTID OCCLUSION (100%) AND BILATERAL ARTERY STENOSIS AS DETERMINED BY ANGIOGRAPHY IN WHICH BOTH CAROTID ARTERIES REQUIRE TREATMENT. PER THE INVESTIGATOR, THE EVENT WAS RELATED TO THE STUDY STENT WHICH WAS FOUND TO BE COMPLETELY OCCLUDED DURING CAROTID DUPLEX. PER THE SITE, THERE IS NO SPECIFICATION ON WHAT OCCLUDED THE STENT. THE PATIENT HAS A MEDICAL HISTORY OF HYPERLIPIDEMIA, SMOKING, DIABETES MELLITUS AND HYPERTENSION. HIGH RISK CRITERIA: CONTRALATERAL CAROTID OCCLUSION, BILATERAL ARTERY STENOSIS AS DETERMINED BY ANGIOGRAPHY IN WHICH BOTH CAROTID ARTERIES REQUIRE TREATMENT AS DEFINED AS: 1) SYMPTOMATIC ON BOTH SIDES WITH >/= 50% STENOSIS, OR 2) ASYMPTOMATIC ON BOTH SIDES WITH >/= 80% STENOSIS, OR 3) SYMPTOMATIC WITH >/= 50% STENOSIS ON ONE SIDE, AND ASYMPTOMATIC WITH >/=80% STENOSIS ON THE OTHER SIDE. 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 15637994 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. CEREBROVASCULAR ACCIDENT IS A WELL DOCUMENTED POTENTIAL COMPLICATION OF CAROTID ARTERY INTERVENTIONS AND IS LISTED IN THE IFU AS SUCH. EMBOLIC STROKES ARE USUALLY CAUSED BY AN EMBOLUS (A BLOOD CLOT THAT FORMS ELSEWHERE IN THE BODY AND TRAVELS THROUGH THE BLOODSTREAM TO THE BRAIN) THAT TRAVELS FROM OTHER PARTS OF THE BODY TO THE NECK OR BRAIN AND BLOCKS A BLOOD VESSEL. EMBOLIC STROKES OFTEN RESULT FROM HEART DISEASE OR HEART SURGERY AND OCCUR RAPIDLY AND WITHOUT ANY WARNING SIGNS. ABOUT 15 PERCENT OF EMBOLIC STROKES OCCUR IN PEOPLE WITH ATRIAL FIBRILLATION. WHEN A CLOT FORMS IN A BLOOD VESSEL IN THE BRAIN OR NECK IT IS CALLED A THROMBOTIC STROKE. EMBOLIC AND THROMBOTIC STROKES ARE CATEGORIZED AS ISCHEMIC STROKE. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, PHARMACEUTICAL, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. ISR IS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. VASCULAR STENT THROMBOSIS IN DEVICE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AND INSTIGATE VESSEL REMODELING AROUND THE STENT, PRODUCING GAPS BETWEEN THE STENT AND THE VESSEL WALL. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.
THE SAPPHIRE STUDY FILE WAS ADJUDICATED. PER THE CEC COMMITTEE, THE PATIENT EXPERIENCED AN ACUTE STENT THROMBOSIS WITHIN THE FIRST 24 HOURS POST PROCEDURE. PER THE COMMITTEE, THE EVENT WAS RELATED TO THE INDEX PROCEDURE AND RELATED TO THE STUDY DEVICE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
AS REPORTED VIA THE (B)(4) REGISTRY, A PATIENT EXPERIENCED AN ISCHEMIC STROKE FIVE DAYS AFTER THE INDEX PROCEDURE. AT THE TIME OF THE PROCEDURE, ANGIOGRAPHY REVEALED 95% STENOSIS IN THE PROXIMAL AND OSTIAL RIGHT INTERNAL CAROTID ARTERY. PRE-PROCEDURE NIH STROKE SCALE SCORE WAS 0 AND THE PATIENT WAS ASYMPTOMATIC. THE LESION WAS DESCRIBED AS 10MM IN LENGTH, SEVERLY CALCIFIED, AORTIC ARCH TYPE I AND ECCENTRIC LESION. THE REFERENCE VESSEL WAS 5.5MM IN DIAMETER WITH MILD TORTUOSITY. A 7MM ANGIOGUARD WAS DEPLOYED BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 8.0 X 30MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. NO NEUROLOGICAL DEFICITS WERE REPORTED WHEN THE PATIENT LEFT THE ANGIOGRAPHY SUITE. IT WAS NOTED, THAT THERE WAS OCCLUSION IN THE CONTRALATERAL CAROTID. AT DISCHARGE, THE NIH STROKE SCALE SCORE WAS 0, THE RANKIN STROKE SCALE WAS NOT PERFORMED AT THIS TIME. THE PATIENT WAS DISCHARGED THE NEXT DAY. CLOPIDOGREL WAS ADMINISTERED AT PRE, POST AND DISCHARGE. NO OTHER INFORMATION WAS PROVIDED. THEN, FIVE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH GAIT INSTABILITY AND LEFT SIDE WEAKNESS. HE WAS ADMITTED AND HAD AN MRI WHERE IT INDICATED RIGHT MIDDLE CEREBRAL ARTERY, LEFT MIDDLE CEREBRAL ARTERY AND RIGHT PROXIMAL CEREBRAL ARTERY CVA SECONDARY TO AN EMBOLIC EVENT. THE PATIENT WAS NOT MEDICALLY TREATED, HOWEVER, WAS BEING FOLLOWED BY PHYSICAL THERAPY. HE WAS TRANSFERRED TO THE ACUTE INPATIENT REHAB WHERE HE IS RECEIVING PHYSICAL THERAPY AND FULLY COOPERATING. THE PATIENT HAS A KNOWN MEDICAL HISTORY OF CONTRALATERAL CAROTID OCCLUSION (100%) AND BILATERAL ARTERY STENOSIS AS DETERMINED BY ANGIOGRAPHY IN WHICH BOTH CAROTID ARTERIES REQUIRE TREATMENT. PER THE INVESTIGATOR, THE EVENT WAS RELATED TO THE (B)(4) STENT WHICH WAS FOUND TO BE COMPLETELY OCCLUDED DURING CAROTID DUPLEX.
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 | 15637994 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| L |