ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2010-00388
- Event Type
- Injury
- Date Received
- December 17, 2010
- Date of Event
- October 1, 2010
- Report Date
- December 8, 2010
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- HDE H60001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
MRI EXAM PERFORM ON (B)(6) 2010 FOR ANEURYSM CONTROL, SHOWING A PARTIAL RECANALIZATION OF THE ANEURYSM WITH A PRESENT AND FUNCTIONAL CAROTID. ANGIOGRAPHIC EXAM PERFORMED ON (B)(6) 2010 SHOWING A THROMBOSIS OF THE LEFT INTRA EXTRA-CRANIAL CAROTID WITH A THROMBOSIS OF THE ANEURYSM. HOWEVER, GOOD SUBSTITUTE OF THE WILLIS POLYGON. PATIENT WAS UNDER PLAVIX/KARDEGIC DURING 6 MONTHS POST PROCEDURE INSTEAD OF 3 MONTHS IN REGARDS OF THE STANDARD OF CARE OF THE CENTER. PLAVIX WAS STOPPED ON THE (B)(6) 2010, AND KARDEGIC WAS STOPPED IN (B)(6) 2010. PATIENT HAS NOT CLINICAL SIGN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
NOTE: LAKE REGION LOT NUMBER 01409647 IS CORDIS LOT NUMBER 13471423. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01409647. 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. (B)(4). THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. MANUFACTURING RECORDS FOR LOT 13471423 WERE REVIEWED AND PRODUCT MET ALL QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. A DHR REVIEW WAS REQUESTED TO (B)(4), AND THE RESULTS INDICATE THAT THE STENT SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
INFORMATION WAS RECEIVED VIA THE (B)(4) STUDY THAT TEN MONTHS AFTER ENTERPRISE VRD ASSISTED COIL EMBOLIZATION, THERE WAS INTRA-STENT THROMBOSIS. IT WAS REPORTED THAT NO TREATMENT WAS CONDUCTED, AND THERE WAS NO VASOSPASM, HYDROCEPHALUS, RE-BLEEDING OR CLINICAL SIGNIFICANCE. AT INDEX PROCEDURE, THE TARGET SITE WAS AN UNRUPTURED SUPRACLINOID CAROTID ARTERY ANEURYSM WHICH WAS DISCOVERED DURING PREVIOUS EMERGENT EMBOLIZATION A RUPTURED ANTERIOR COMMUNICATING (ACOM) ANEURYSM, EXTERNAL VENTRICULAR DRAINAGE FOLLOWED BY PERITONEAL VENTRICULAR DRAIN. THE PATIENT HAD NUMEROUS COGNITIVE AND NEUROLOGICAL SEQUELAE INCLUDING CONFUSION, SPATIAL-TEMPORAL DISTURBANCE, INABILITY TO STATE DATE/TIME AND LANGUAGE DIFFICULTIES. THERE WAS SIGHT RIGHT HEMIPARESIS, PROBABLE VISUAL ATAXIA, AND INABILITY TO WALK WITHOUT ASSISTANCE. NO FURTHER INFORMATION REGARDING TREATMENT OF THE ACOM ANEURYSM IS AVAILABLE. THE PRE INDEX PROCEDURE MODIFIED RANKIN SCALE (MRS) WAS 5. THE TARGET ANEURYSM HAD A SAC HEIGHT OF 12.4, SAC WIDTH OF 12MM, NECK OF 10MM, AND WFNS SCALE OF 0. THE TARGET ANEURYSM WAS EMBOLIZED WITH NO PROCEDURAL OR DEVICE ADVERSE EVENT. IT WAS REPORTED THAT THE ENTERPRISE STENT WAS IN GOOD PLACE AND WELL DEPLOYED. THE STENT FULLY EXPANDED AND APPOSED THE VESSEL WALL AFTER PLACEMENT. 20 MICRUS COILS WERE PLACED VIA A MICROCATHETER THROUGH THE STENT. THE PARENT VESSEL WAS WELL PERFUSED. THERE WERE NO PROCEDURAL OR DEVICE ASSOCIATED ADVERSE EVENTS. TREATMENT WAS ACHIEVED WITH COMPLETE OCCLUSION OF THE ANEURYSM. THE PATIENT WAS DISCHARGED THREE DAYS POST PROCEDURE WITHOUT ADVERSE EVENT. ANTIPLATELET THERAPY INCLUDED PLAVIX/KARDEGIC FOR SIX MONTHS POST PROCEDURE INSTEAD OF THE 3 MONTHS PER STANDARD OF CARE OF THE CENTER. NO ANTI-COAGULATION OR ANTIPLATELET MEASUREMENT WAS PERFORMED PRE, INTRA AND POST PROCEDURE. IT WAS INDICATED THAT THERE WERE NO ADVERSE EVENTS AT 30 DAY FOLLOW-UP. CONTROL MRI APPROXIMATELY SIX MONTHS POST PROCEDURE REPORTED PARTIAL RECANALIZATION OF THE ANEURYSM WITH A PRESENT AND FUNCTIONAL LEFT CAROTID AND SLIGHT RESIDUAL NECK OF THE ACOM ANEURYSM TREATED PRIOR TO INDEX PROCEDURE. ANGIOGRAPHIC CONTROL APPROXIMATELY TEN MONTHS POST INDEX PROCEDURE REPORTED SHOWING A THROMBOSIS OF THE LEFT INTRA EXTRA -CRANIAL CAROTID WITH A THROMBOSIS OF THE ANEURYSM. THERE WAS LEFT CAROTID EXCLUSION WITH A TOTAL THROMBOSIS. IT WAS REPORTED THAT THE THROMBOSIS WAS PROBABLY DUE TO OCCLUSION AND THROMBOSIS OF THE STENT. THERE WAS GOOD COLLATERAL VIA THE CIRCLE OF WILLIS AND THE PATIENT DID NOT HAVE ANY CLINICAL SYMPTOMS. THE ENTERPRISE VRD REMAINS IMPLANTED AND THEREFORE IS NOT AVAILABLE FOR ANALYSIS. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01409647 WHICH CORRESPONDS TO FINAL LOT 13471423. 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. MANUFACTURING RECORDS FOR LOT 13471423 WERE REVIEWED AND PRODUCT MET ALL QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. A DHR REVIEW WAS REQUESTED TO (B)(4) AND THE RESULTS INDICATE THAT THE STENT SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. STENT THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AS OUTLINED IN THE INSTRUCTIONS FOR USE. ALTHOUGH BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE, PATIENT/PHARMACOLOGICAL FACTORS SUCH AS RESPONSIVENESS TO ANTIPLATELET THERAPY 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 (B)(6) STUDY INDICATED THE PATIENT (ID#(B)(6)) HAD INTRA-STENT THROMBOSIS TEN MONTHS AFTER UNDERGOING ENTERPRISE STENT ASSISTED COIL EMBOLIZATION WITH NON-CORDIS DEVICES (MICRUS). ACCORDING TO THE REPORT NO TREATMENT WAS CONDUCTED, AND THERE WAS NO VASOSPASM, HYDROCEPHALUS, RE-BLEEDING OR CLINICAL SIGNIFICANCE. AN MRI EXAM PERFORMED, AT SIX MONTHS POST INDEX PROCEDURE, SHOWED A PARTIAL RECANALIZATION OF THE ANEURYSM WITH A PRESENT AND FUNCTIONAL CAROTID. ANGIOGRAPHIC EXAM PERFORM AT TEN MONTHS POST INDEX PROCEDURE, SHOWED THROMBOSIS OF THE LEFT INTRA EXTRA -CRANIAL CAROTID WITH A THROMBOSIS OF THE ANEURYSM. HOWEVER, GOOD SUBSTITUTE OF THE WILLIS POLYGON. PATIENT WAS UNDER PLAVIX/KARDEGIC DURING 6 MONTHS POST PROCEDURE INSTEAD OF 3 MONTHS IN REGARDS OF THE STANDARD OF CARE OF THE CENTER. PLAVIX WAS STOPPED ON THE AFTER SIX MONTHS, AND KARDEGIC WAS STOPPED IN AFTER EIGHT MONTHS. PATIENT HAS NOT CLINICAL SIGN. THE ANGIOGRAPHIC CONTROL PERFORMED TEN MONTHS AFTER THE INDEX PROCEDURE, REVEALED A LEFT CAROTID EXCLUSION WITH A TOTAL THROMBOSIS. THROMBOSIS WAS PROBABLY DUE TO OCCLUSION AND THROMBOSIS OF THE STENT, DESPITE ANTIPLATELET MEDICATION DURING MORE THAN 6 MONTHS POST PROCEDURE (3 MONTH STANDARD OF CARE) AND STOP AFTER SIX MONTHS POST PROCEDURE. THERE WAS NO MENTION OF ANY INDICATIONS OF ANY HYPERCOAGULABLE STATE. THE PRE-PROCEDURE (MRS) MODIFIED RANKIN SCALE WAS 5. THE 22MM ENTERPRISE WAS PLACED AT THE SITE AND THE NON-CORDIS COILS WERE PLACED THROUGH A MICROCATHETER/STENT. NO BALLOON WAS UTILIZED. TREATMENT WAS ACHIEVED AND ANGIOGRAPHICALLY ANEURYSM WAS COMPLEXLY OCCLUDED, AND THE POST-PROCEDURE MRS WAS 5. ASPIRIN AND PLAVIX WERE GIVEN PRE, INTRA AND POST PROCEDURE, AND HEPARIN DURING THE PROCEDURE. NO ADVERSE EVENT WAS REPORTED DURING THE INDEX PROCEDURE. THE PATIENT WAS DISCHARGED ON PLAVIX THREE DAYS AFTER THE INDEX PROCEDURE. DURING THE INDEX PROCEDURE, THE TARGET SITE WAS THE LEFT SUPRACLINOID CAROTID WITH A NON-RUPTURED ANEURYSM SAC HEIGHT OF 12.4, SAC WIDTH OF 12MM, NECK OF 10MM, AND (B)(6) SCALE OF 0. THE PATIENT HAD A PREVIOUS SUB-ARACHNOID HEMORRHAGE GREATER THAN ONE MONTH. THE TARGET ANEURYSM (UNRUPTURED LEFT, SUPRACLINOID CAROTID ANEURYSM) WAS DISCOVERED DURING THE PROCEDURE OF THE FIRST RUPTURED ANEURYSM (RUPTURED ANTERIOR COMMUNICATING ANEURYSM IN (B)(6) 2009). THE TARGET ANEURYSM WAS EMBOLIZED WITH NO PROCEDURAL OR DEVICE ADVERSE EVENT. STENT WAS IN GOOD PLACE AND WELL DEPLOYED, PARENT VESSEL WAS WELL PERFUSED. ON INITIAL ANGIOGRAMS, THE TARGET SITE WAS NOT OCCLUDED AND NO THROMBUS WAS OBSERVED. THE PERCENTAGE OF STENOSIS WAS UNKNOWN, BUT THERE WAS PARTIAL PERMEABILITY. AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, THE VESSEL AND STENTED AREA WAS PATENT. NO INFORMATION WAS AVAILABLE REGARDING VESSEL SIZE PROXIMAL/DISTAL TO ANEURYSM NECK. THE ENTERPRISE WAS FULLY EXPANDED AND OPPOSED TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THERE WAS NO COMPLICATION OBSERVED DURING THE PROCEDURE. THE ENTERPRISE WAS FULLY EXPANDED, OPPOSED TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. NO ANTI-COAGULATION OR ANTIPLATELET MEASUREMENT WAS PERFORMED PRE, INTRA AND POST PROCEDURE. THE ANEURYSM WAS SACCULAR. BEFORE THE INDEX PROCEDURE, THE PATIENT HAD A MODIFIED RANKIN SCORE OF 5, THE PATIENT WAS CONFUSED, PERTURBATION OF HER SPATIO TEMPORAL ORIENTATION, UNABLE TO SAY THE HOURS OR THE DATE, LANGUAGE PERTURBATION, SLIGHT RIGHT HEMIPARESIA, PROBABLE VISUAL ATAXIA, AND UNABLE TO WALK WITHOUT ASSISTANCE (NEED ASSISTANCE). PRE-PROCEDURE MEDICATION CONSISTED OF LOXEN LP 50MG 2CAPS/DAY, ATENOLOL SANDOZ 50MG 2TAB/DAY, TAHOR 40MG 1 TAB/DAY, DIFFU K 500MG 1CAPS/DAY, TRIATEC 10MG 10MG/DAY, AND KEPPRA 500MG 1CAPS/DAY. THE 30 FOLLOW-UP INDICATED THAT THE PATIENT'S MRS CONTINUES TO BE 5, AND THERE WERE NO ADVERSE EVENTS. THE ANGIOGRAM PERFORMED SIX MONTHS AFTER THE INDEX PROCEDURE SHOWED PARTIAL PERMEABILITY OF TARGET ANEURYSM, LIGHT RESIDUAL NECK FOR THE INITIAL RUPTURED ANTERIOR COMMUNICATING ANEURYSM, HEMORRHAGE SEQUELAE (SUPERFICIAL HEMOSIDEROSIS) AND ISCHEMIC SEQUELAE (LEFT OCCIPITAL), POSSIBLE HYPER DRAINAGE OF THE LEFT VENTRICULO PERITONEAL DERIVATION, AND LEFT CAROTID PERMEABLE. NOTE: LAKE REGION LOT NUMBER 01409647 IS CORDIS LOT NUMBER 13471423. PER LAKE REGION REPORT (B)(4) - LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01409647. 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. (B)(4). THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. MANUFACTURING RECORDS FOR LOT 13471423 WERE REVIEWED AND PRODUCT MET ALL QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. A DHR REVIEW WAS REQUESTED TO NITINOL DEVICES & COMPONENTS (NDC) (B)(4), AND THE RESULTS INDICATE THAT THE STENT SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE (B)(4) STUDY INDICATED THE PATIENT (B)(4) HAD INTRA-STENT THROMBOSIS TEN MONTHS AFTER UNDERGOING ENTERPRISE STENT ASSISTED COIL EMBOLIZATION WITH NON-CORDIS DEVICES (MICRUS). ACCORDING TO THE REPORT NO TREATMENT WAS CONDUCTED, AND THERE WAS NO VASOSPASM, HYDROCEPHALUS, RE-BLEEDING OR CLINICAL SIGNIFICANCE. DURING THE INDEX PROCEDURE, THE TARGET SITE WAS THE LEFT SUPRACLINOID CAROTID WITH A NON-RUPTURED ANEURYSM SAC HEIGHT OF 12.4, SAC WIDTH OF 12MM, NECK OF 10MM, AND WFNS SCALE OF 0. THE PATIENT HAD A PREVIOUS SUB-ARACHNOID HEMORRHAGE GREATER THAN ONE MONTH. THE PRE-PROCEDURE (MRS) MODIFIED RANKIN SCALE WAS 5. THE 22MM ENTERPRISE WAS PLACED AT THE SITE AND THE NON-CORDIS COILS WERE PLACED THROUGH A MICROCATHETER/STENT. NO BALLOON WAS UTILIZED. TREATMENT WAS ACHIEVED AND ANGIOGRAPHICALLY ANEURYSM WAS COMPLEXLY OCCLUDED, AND THE POST-PROCEDURE MRS WAS 5. ASPIRIN AND PLAVIX WERE GIVEN PRE, INTRA AND POST PROCEDURE, AND HEPARIN DURING THE PROCEDURE. NO ADVERSE EVENT WAS REPORTED DURING THE INDEX PROCEDURE. THE PATIENT WAS DISCHARGED ON PLAVIX THREE DAYS AFTER THE INDEX PROCEDURE. THE 30 FOLLOW-UP INDICATED THAT THE PATIENT'S MRS CONTINUES TO BE 5, AND THERE WERE NO ADVERSE EVENTS.
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 | 13471423 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| L | MICROCATHRTER AND COILS |