ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2011-00165
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- November 1, 2012
- Report Date
- March 16, 2011
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
DURING STENT ASSISTED COILING OF A LEFT INTERNAL CAROTID (IC) ARTERY ANEURYSM THERE WAS INABILITY TO ADVANCE TWO ENTERPRISE VRDS ((B)(4)/LOT 01418203 & (B)(4)/LOT 13471872) THROUGH A PROWLER SELECT PLUS ((B)(4)/LOT 15165078) MICROCATHETER (MC). AFTER EXCHANGE OF THE MC, WITHOUT LOSS OF TARGET SITE POSITION, THE SECOND ENTERPRISE WAS ABLE TO BE SUCCESSFULLY DEPLOYED WITHOUT ANY INTRAPROCEDURAL COMPLICATIONS. ONE DAY POST PROCEDURE THE PATIENT EXPERIENCED A SMALL CEREBRAL INFARCTION WITH FULL RECOVERY. SIX MONTHS LATER ANOTHER UNRELATED TARGET SITE, A RUPTURED VERTEBRAL ARTERY (VA) ANEURYSM WAS TREATED VIA STENT ASSISTED COIL EMBOLIZATION WITH AN ENTERPRISE VRD (B)(4) WITH REPORT OF A CEREBRAL INFARCTION POSSIBLY RELATED TO THROMBUS FROM THE IC VRD. THIS EVENT WAS TREATED MEDICALLY WITH THE OUTCOME APPROXIMATELY SIX MONTHS LATER INDICATED AS "ONGOING/IMPROVED". AT INDEX PROCEDURE THE IC ARTERY TARGET SITE WAS NOT CALCIFIED OR TORTUOUS. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.9MM AND DISTALLY WAS 3.5MM. THE PRODUCTS WERE INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCTS WERE PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. AN ADEQUATE/CONTINUOUS FLUSH WAS MAINTAINED TO THE MC AT ALL TIMES. THERE WAS NO KINK OR BEND NOTED UPON INSPECTION THAT MAY HAVE CONTRIBUTED TO THE PRODUCT ISSUE. IT WAS REPORTED THAT THE OBSTRUCTION OF THE MC WAS NOT RELATED TO A BLOCKAGE BY FOREIGN MATERIAL. THE PATIENT WAS ON ASPIRIN 100MG/DAY STARTING APPROXIMATELY 2 MONTHS PRIOR TO INDEX PROCEDURE. PLAVIX 75MG/DAY WAS PRESCRIBED 12 DAYS PRE-PROCEDURE UNTIL SEVEN WEEKS POST PROCEDURE FOLLOWED BY DAILY CILOSTAZOL 200MG/DAY. BASELINE ACT IS UNKNOWN. INTRA-PROCEDURE HEPARIN 7000 UNITS WAS GIVEN WITH AN ACT OF 253 SECONDS. ADDITIONAL MEDICATIONS INCLUDED ARGATROBAN THE DAY OF INDEX PROCEDURE; TAPERING OFF OVER THREE DAYS. THE PATIENT EXPERIENCED A SMALL CEREBRAL INFARCTION THE DAY AFTER THE PROCEDURE CONFIRMED BY MRI. NO THROMBUS WAS OBSERVED IN THE IMPLANTED ENTERPRISE VRD. THE PATIENT RECOVERED. NO TREATMENT WAS RENDERED. THE PATIENT WAS ASYMPTOMATIC. ADDITIONAL INFORMATION REPORTED THAT APPROXIMATELY 6 AND A HALF MONTHS POST INDEX TREATMENT OF THE IC ANEURYSM THE PATIENT DEVELOPED A SUBARACHNOID HEMORRHAGE DUE TO A RUPTURED VERTEBRAL ARTERY (VA) TRUNK ANEURYSM WHICH WAS TREATED WITH STENT ASSISTED COIL EMBOLIZATION WITH PLACEMENT OF AN ENTERPRISE VRD ((B)(4)) AND UNKNOWN MEDICATION. THE ACT WAS 123 SECONDS PRE ANTICOAGULATION AND 222 SECONDS POST ANTICOAGULATION. TWO DAYS POST TREATMENT OF THE VA ANEURYSM THE PATIENT DEVELOPED CEREBRAL INFARCTION WITH RIGHT SIDED HEMIPLEGIA. THE EXACT LOCATION OF THE INFARCTION WAS UNSPECIFIED BUT WAS REPORTED AS INVOLVING THE LOWER SECTION OF THE LEFT IC. ACCORDING TO THE PHYSICIAN, THE POSSIBLE CAUSE OF THE EVENT WAS THAT THE THROMBUS IN THE VRD MIGHT HAVE TRAVELED PERIPHERALLY. THIS EVENT WAS TREATED MEDICALLY WITH THE OUTCOME APPROXIMATELY SIX MONTHS LATER INDICATED AS "ONGOING/IMPROVED". ONGOING CLOPIDOGREL 75MG/DAY WAS RESUMED. THE MODIFIED RANKIN SCALE SCORE PRIOR TO THE TREATMENT OF THE RUPTURED VA ANEURYSM AND FIVE DAYS LATER WAS 5. THE ONE-YEAR FOLLOW UP ANGIOGRAM REVEALED AN ANEURYSM GROWTH OF THE 1ST LESION (LEFT PARACELLAR WHERE (B)(4) WAS PLACED). THE OCCLUSION RATE OF THE ANEURYSM AT ONE YEAR FOLLOW-UP WAS 50% COMPARED TO 95% POST INDEX COILING USING V-TRACK(TOTAL 4), DELTAPLUSH 10(TOTAL 14), DELTAPAQ 10(TOTAL 3), CASHMERE 14(TOTAL 4). THE ANEURYSM NECK TO SAC RATIO WAS 9.0MM: 9.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.9MM AND DISTALLY WAS 3.5MM, AND MODIFIED RANKIN SCORE (MRS WAS 3). THE PHYSICIAN CONSIDERED THAT IT WAS A NATURAL COURSE OF THE SYMPTOM AND NO ACTION WAS TAKEN. THE EVENT OUTCOME ONE MONTH POST ONE YEAR FOLLOW-UP WAS INDICATED AS "ONGOING, UNCHANGED". (B)(4): THE ENTERPRISE VRD REMAINS IMPLANTED. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01419843. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE STENT REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. CEREBRAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AND THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. ALTHOUGH BASED ON THE AVAILABLE INFORMATION AND WITHOUT PROCEDURAL/DIAGNOSTIC IMAGES NO DEFINITIVE CONCLUSION CAN BE MADE, PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE CEREBRAL INFARCTION ONE DAY POST INDEX PROCEDURE. IT IS POSSIBLE THAT PHYSIOLOGICAL FACTORS RELATED TO THE NONTARGET SITE RUPTURED ANEURYSM CONTRIBUTED TO THE SECOND CEREBRAL INFARCTION. THERE HAVE BEEN STUDIES SHOWING EVIDENCE FOR A GENERALIZED STRONG ACTIVATION OF THE COAGULATION AND FIBRINOLYTIC SYSTEM IN PATIENTS WITH SUBARACHNOID HEMORRHAGE. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
INFORMATION WAS INITIALLY RECEIVED THAT THE FIRST ENTERPRISE VRD ((B)(4)/LOT 01418203) BECAME STUCK AT THE AREA OF THE PROXIMAL MARKER OF THE PROWLER SELECT PLUS 150/5CM MICROCATHETER ((B)(4)/LOT 15165078). THE DEVICE WAS REMOVED AND THE SAME THING OCCURRED WITH ATTEMPTED ADVANCEMENT OF A SECOND ENTERPRISE VRD ((B)(4)/LOT 13471872) THROUGH THE SAME MICROCATHETER (MC). THE MC WAS EXCHANGED AND THE SECOND ENTERPRISE WAS ABLE TO BE DEPLOYED SUCCESSFULLY AT THE SITE WITH NO PATIENT INJURY OR NEUROLOGICAL EVENT. THERE WAS NO LOSS OF TARGET SITE POSITION DUE TO THE EVENT. ADDITIONAL RECEIVED INFORMATION REPORTED THAT THE PATIENT EXPERIENCED A SMALL CEREBRAL INFARCTION THE DAY AFTER THE PROCEDURE CONFIRMED BY MRI. THE PATIENT RECOVERED. NO TREATMENT WAS RENDERED. THE PATIENT WAS ASYMPTOMATIC. THE TARGET LESION WAS AN ANEURYSM OF THE INTERNAL CAROTID ARTERY. THE TARGET LESION WAS NOT CALCIFIED OR TORTUOUS. THE PRODUCTS WERE INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCTS WERE PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. AN ADEQUATE/CONTINUOUS FLUSH WAS MAINTAINED TO THE MC AT ALL TIMES. THERE WAS NO KINK OR BEND NOTED UPON INSPECTION THAT MAY HAVE CONTRIBUTED TO THE PRODUCT ISSUE. IT WAS REPORTED THAT THE OBSTRUCTION OF THE MC WAS NOT RELATED TO A BLOCKAGE BY FOREIGN MATERIAL. THE PATIENT WAS ON ASPIRIN 100MG/DAY STARTING APPROXIMATELY 2 MONTHS PRIOR TO INDEX PROCEDURE. PLAVIX 75MG/DAY WAS PRESCRIBED 12 DAYS PRE-PROCEDURE UNTIL SEVEN WEEKS POST PROCEDURE FOLLOWED BY DAILY CILOSTAZOL 200MG/DAY. BASELINE ACT IS UNKNOWN. INTRA-PROCEDURE HEPARIN 7000 UNITS WAS GIVEN WITH AN ACT OF 253 SECONDS. ADDITIONAL MEDICATIONS INCLUDED ARGATROBAN THE DAY OF INDEX PROCEDURE; TAPERING OFF OVER THREE DAYS. (B)(4): THE PRODUCT WAS NOT RETURNED FOR INSPECTION. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01419843. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE STENT REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. CEREBRAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AND THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. ALTHOUGH BASED ON THE AVAILABLE INFORMATION AND WITHOUT PROCEDURAL/DIAGNOSTIC IMAGES NO DEFINITIVE CONCLUSION CAN BE MADE, PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
THE INFORMATION WAS UPDATED TO INDICATE THAT VRD THROMBOSIS WAS REVEALED. ACTION TAKEN WAS MEDICATION. THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS INDICATED AS UNKNOWN BUT TO THE VRD WAS HIGHLY PROBABLE BECAUSE THE PHYSICIAN CONSIDERED THAT THE VRD HAD PROMOTED THROMBUS FORMATION IN THE VRD. ON THE SAME DAY, THE PATIENT DEVELOPED CEREBRAL INFARCTION. ALSO, THE ANEURYSM NECK TO SAC RATIO WAS UPDATED TO 15.0MM:10.1 MM. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE INFORMATION WAS UPDATED TO INDICATE THAT VRD THROMBOSIS WAS REVEALED. ACTION TAKEN WAS MEDICATION. THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS INDICATED AS UNKNOWN BUT TO THE VRD WAS HIGHLY PROBABLE BECAUSE THE PHYSICIAN CONSIDERED THAT THE VRD HAD PROMOTED THROMBUS FORMATION IN THE VRD. ON THE SAME DAY, THE PATIENT DEVELOPED CEREBRAL INFARCTION. ALSO, THE ANEURYSM NECK TO SAC RATIO WAS UPDATED TO 15.0 MM:10.1 MM. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01419843. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE STENT REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. STENT THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AND THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. ALTHOUGH BASED ON THE AVAILABLE INFORMATION AND WITHOUT PROCEDURAL/DIAGNOSTIC IMAGES NO DEFINITIVE CONCLUSION CAN BE MADE, PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE CEREBRAL INFARCTION ONE DAY POST INDEX PROCEDURE. IT IS POSSIBLE THAT PHYSIOLOGICAL FACTORS RELATED TO THE NONTARGET SITE RUPTURED ANEURYSM CONTRIBUTED TO THE SECOND STENT THROMBOSIS AND CEREBRAL INFARCTION. THERE HAVE BEEN STUDIES SHOWING EVIDENCE FOR A GENERALIZED STRONG ACTIVATION OF THE COAGULATION AND FIBRINOLYTIC SYSTEM IN PATIENTS WITH SUBARACHNOID HEMORRHAGE. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
CONCOMITANT PRODUCTS: GC:6F LAUNCHER; MC: PROWLER SELECT PLUS; SL10 GW:CHIKAI; SHEATH: 7F TERUMO. THE PRODUCTS WERE INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCTS WERE PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. AN ADEQUATE/CONTINUOUS FLUSH WAS MAINTAINED TO THE MC AT ALL TIMES. THERE WAS NO KINK OR BEND NOTED UPON INSPECTION THAT MAY HAVE CONTRIBUTED TO THE PRODUCT ISSUE. THE OBSTRUCTION OF THE MC WAS NOT RELATED TO A BLOCKAGE BY FOREIGN MATERIAL. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING AN STENT ASSISTED COIL EMBOLIZATION, THE PHYSICIAN WAS ADVANCING THE ENTERPRISE VRD STENT (COMPLAINT PRODUCT #1) TO THE INTENDED TARGET LESION VIA THE PROWLER SELECT PLUS MICRO-CATHETER (MC/COMPLAINT PRODUCT #2) WHEN IT BECAME STUCK AT THE PROXIMAL MARKER OF THE MC. THE DEVICE WAS REMOVED AND THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER UNKNOWN ENTERPRISE VRD STENT THROUGH THE SAME MC AND IT AGAIN BECAME STUCK. THE PHYSICIAN THEN EXCHANGED TO ANOTHER MC AND THE SECOND ENTERPRISE VRD DEVICE WAS DEPLOYED SUCCESSFULLY AT THE TARGET LESION. THERE WAS NO REPORTED LOSS OF ACCESS TO THE INTENDED TARGET LESION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR ANY PATIENT NEUROLOGICAL SYMPTOMS REPORTED POST-PROCEDURE. THE TARGET LESION WAS AN ANEURYSM OF THE INTERNAL CAROTID ARTERY. THE TARGET LESION WAS NOT CALCIFIED OR TORTUOUS. ADDENDUM: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED A SMALL CEREBRAL INFARCTION THE DAY AFTER THE PROCEDURE CONFIRMED BY MRI AND RECOVERED. NO TREATMENT WAS RENDERED. THE PATIENT WAS ASYMPTOMATIC.
THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A STENT ASSISTED COIL EMBOLIZATION, THE PHYSICIAN WAS ADVANCING THE ENTERPRISE VRD STENT (COMPLAINT PRODUCT #1) TO THE INTENDED TARGET LESION VIA THE PROWLER SELECT PLUS MICRO-CATHETER (MC/COMPLAINT PRODUCT #2) WHEN IT BECAME STUCK AT THE PROXIMAL MARKER OF THE MC. THE DEVICE WAS REMOVED AND THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER UNKNOWN ENTERPRISE VRD STENT THROUGH THE SAME MC AND IT AGAIN BECAME STUCK. THE PHYSICIAN THEN EXCHANGED TO ANOTHER MC AND THE SECOND ENTERPRISE VRD DEVICE WAS DEPLOYED SUCCESSFULLY AT THE TARGET LESION. THERE WAS NO REPORTED LOSS OF ACCESS TO THE INTENDED TARGET LESION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR ANY PATIENT NEUROLOGICAL SYMPTOMS REPORTED POST-PROCEDURE. THE TARGET LESION WAS AN ANEURYSM OF THE INTERNAL CAROTID ARTERY. THE TARGET LESION WAS NOT CALCIFIED OR TORTUOUS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED A SMALL CEREBRAL INFARCTION THE DAY AFTER THE PROCEDURE CONFIRMED BY MRI AND RECOVERED. NO TREATMENT WAS RENDERED. THE PATIENT WAS ASYMPTOMATIC. ADDENDUM: ADDITIONAL INFORMATION RECEIVED INDICATED THAT AT THE 1-YEAR F/U, THE PATIENT EXPERIENCED GROWTH OF THE ANEURYSM-NO ACTION TAKEN. SIX MONTHS LATER, THE PATIENT EXPERIENCED SUBARACHNOID HEMORRHAGE DUE TO RUPTURED ANEURYSM IN VA-TRUNK TREATED BY IMPLANTATION OF ANOTHER ENTERPRISE AND ORBIT COILS. TWO DAYS LATER, THE PATIENT EXPERIENCED A CEREBRAL INFARCTION RELATED TO THE LEFT INTERNAL CAROTID ANEURYSM (1ST LESION TREATED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM | CNV ENTERPRISE SES (NJE) | NJE | CORDIS NEUROVASCULAR, INC. | NA | 13471872 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L |