ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2010-00308
- Event Type
- Injury
- Date Received
- October 25, 2010
- Date of Event
- August 20, 2010
- Report Date
- October 1, 2010
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- HDE H60001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
INFORMATION WAS RECEIVED VIA THE (B)(4) STUDY THAT DURING AN ENTERPRISE ASSISTED COIL EMBOLIZATION OF A BASILAR ARTERY ANEURYSM, ISCHEMIC THROMBUS WAS OBSERVED VIA FLUOROSCOPY IN THE SUPERIOR CEREBELLAR ARTERY. THE TIMING OF THE EVENT DURING THE PROCEDURAL IS NOT KNOWN. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE WITHOUT ANY REPORT OF ADDITIONAL TREATMENT. IT WAS REPORTED THAT THERE WERE NO ISSUES WITH ANY DEVICES DURING THE PROCEDURE THAT MAY HAVE CAUSED THE EVENT. NYSTAGMUS WAS OBSERVED THE DAY AFTER THE PROCEDURE. MEDICAL TREATMENT INCLUDED OZAGREL SODIUM AND EDARAVONE. THE NYSTAGMUS RESOLVED A DAY LATER WITH REPORTED PATIENT RECOVERY. IT WAS REPORTED THAT THE PHYSICIAN COMMENTED THAT THE NYSTAGMUS COULD BE CAUSED BY "FLOWN THROMBOSIS." IT WAS REPORTED THAT IT WAS CONSIDERED THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE ENTERPRISE. THE PATIENT WAS ASYMPTOMATIC AT BASELINE WITH NO ISCHEMIA OR THROMBUS. THE ANEURYSM NECK WAS 5.6MM AND THE ANEURYSM SAC WAS 6.4MM. THE PARENT VESSEL PROXIMAL AND DISTAL TO THE ANEURYSM NECK WAS 2.0MM. THE ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY AND CLOPIDOGREL 75MG/DAY BEGINNING FOUR DAYS PRIOR TO THE INDEX PROCEDURE. IT IS NOT KNOWN IF ACT WAS MEASURED DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AND REQUESTED PROCEDURAL CD IS NOT AVAILABLE. THE ENTERPRISE STENT REMAINS IMPLANTED. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01419558. 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. THROMBOEMBOLIC EVENTS AND ACCOMPANYING NEUROLOGICAL SYMPTOMS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STENT ASSISTED COIL EMBOLIZATIONS. BASED ON THE LIMITED AVAILABLE PROCEDURAL INFORMATION, NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE DEVICE TO THE EVENT. IT IS POSSIBLE THAT PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. WITH REVIEW OF THE DEVICE HISTORY RECORDS AND AVAILABLE INFORMATION, THERE IS NO INDICATION OF ANY DEVICE DESIGN OR MANUFACTURING RELATED ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.
INFORMATION WAS RECEIVED VIA THE (B)(6) STUDY THAT DURING AN ENTERPRISE ASSISTED COIL EMBOLIZATION OF A BASILAR ARTERY ANEURYSM, ISCHEMIC THROMBUS WAS OBSERVED VIA FLUOROSCOPY IN THE SUPERIOR CEREBELLAR ARTERY. THE TIMING OF THE EVENT DURING THE PROCEDURAL IS NOT KNOWN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS POSSIBLE THAT THE MANIPULATION OF DEVICES CAUSED THROMBUS MOVEMENT/FLOW INTO THE VESSEL AND THAT A PROWLER SELECT PLUS 150/5CM MICROCATHETER WAS USED WITH THE ENTERPRISE VRD. IT WAS ADDITIONALLY REPORTED THAT THE MICROCATHETER CANNOT BE DISASSOCIATED FROM THE EVENT. A NONCORDIS CHIKAI 0.014 200CM GUIDEWIRE WAS USED TO POSITION THE MICROCATHETER AT THE TARGET SITE. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE WITHOUT ANY REPORT OF ADDITIONAL TREATMENT. IT WAS REPORTED THAT THERE WERE NO ISSUES WITH ANY DEVICES DURING THE PROCEDURE THAT MAY HAVE CAUSED THE EVENT. NYSTAGMUS WAS OBSERVED THE DAY AFTER THE PROCEDURE. MEDICAL TREATMENT INCLUDED OZAGREL SODIUM AND EDARAVONE. THE NYSTAGMUS RESOLVED A DAY LATER WITH REPORTED PATIENT RECOVERY. IT WAS REPORTED THAT THE PHYSICIAN COMMENTED THAT THE NYSTAGMUS COULD BE CAUSED BY 'FLOWN THROMBOSIS.' IT WAS REPORTED THAT IT WAS CONSIDERED THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE ENTERPRISE. THE PATIENT WAS ASYMPTOMATIC AT BASELINE WITH NO ISCHEMIA OR THROMBUS. THE ANEURYSM NECK WAS 5.6MM AND THE ANEURYSM SAC WAS 6.4MM. THE PARENT VESSEL PROXIMAL AND DISTAL TO THE ANEURYSM NECK WAS 2.0MM. THE ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY AND CLOPIDOGREL 75MG/DAY BEGINNING FOUR DAYS PRIOR TO THE INDEX PROCEDURE. IT IS NOT KNOWN IF ACT WAS MEASURED DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AND REQUESTED PROCEDURAL CD IS NOT AVAILABLE. FOLLOW-UP INFORMATION REPORTED THAT THE PATIENT IS IN STABLE CONDITION. THE ENTERPRISE STENT REMAINS IMPLANTED AND THE DELIVERY SYSTEM IS NOT AVAILABLE FOR ANALYSIS. (B)(4). THROMBOEMBOLIC EVENTS AND ACCOMPANYING NEUROLOGICAL SYMPTOMS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STENT ASSISTED COIL EMBOLIZATIONS. BASED ON THE LIMITED AVAILABLE PROCEDURAL INFORMATION, NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE DEVICES TO THE EVENT. IT IS POSSIBLE THAT PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. WITH REVIEW OF THE DEVICE HISTORY RECORDS AND AVAILABLE INFORMATION, THERE IS NO INDICATION OF ANY DEVICE DESIGN OR MANUFACTURING RELATED ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00308 AND 1058196-2011-00024.
LR PACKAGING L/N# 01419558, 13471855. PER LAKE REGION REPORT C 9,598: LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01419558. 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THROMBUS WAS PRESENT AT THE ORIGINATION OF RIGHT SCA (SUPERIOR CEREBELLAR ARTERY) DURING THE PROCEDURE. IT WAS POSSIBLE THE MANIPULATION OF DEVICES CAUSED THROMBUS MOVED /FLOWED INTO THE VESSEL. THE MC (B)(4) (LOT 15165079) WAS UTILIZED FOR THE PROCEDURE, AND THE CAUSALITY CAN'T BE DENIED. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00308 AND 1058196-2011-00024. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
THE PRODUCTS ARE NOT GOING TO BE RETURNED FOR ANALYSIS. THE GUIDEWIRE UTILIZED TO DELIVER THE MICROCATHETER WAS A CHIKAI, 0.014INCH 200CM, AND IT WAS NOT INVOLVED IN THE EVENT. THE CURRENT PATIENT CONDITION IS STABLE. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00308 AND 1058196-2011-00024. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
PRIOR TO THE PROCEDURE, THE PATIENT DID NOT HAVE ANY NEUROLOGICAL SYMPTOMS/DEFICITS, AND THE ANEURYSM WAS NOT RUPTURED. THE PRE-PROCEDURE MEDICATION CONSISTED OF ASPIRIN 100MG/DAY, CLOPIDOGREL SULFATE 75MG/DAY, AND INTRA-PROCEDURE WAS HEPARIN 1200U/DAY. THE ANEURYSM MEASUREMENT WAS NECK 5.6MM, AND NECK TO SAC RATIO 5.6MM/6.4MM. THERE WERE NO ISSUES DURING THE PROCEDURE WITH ANY OF THE DEVICES THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO FILMS ARE AVAILABLE FOR THE EVENT, AND NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
PT WAS REVISED TO ADDRESS A STEM THAT WAS TOO SMALL AND IN VARUS.
THIS COMPLAINT IS FROM A (B)(4). THE DAY AFTER COIL EMBOLIZATION PROCEDURE OF THE BASILAR ARTERY ASSISTED WITH AN ENTERPRISE (ENC452212) STENT, THE PATIENT HAD NYSTAGMUS. THE EVENT WAS TREATED WITH (OZAGREL SODIUM, EDARAVONE) AND THE FOLLOWING DAY THE NYSTAGMUS DISAPPEARED AND THE PATIENT RECOVERED. THE PHYSICIAN COMMENTED THAT THROMBOSIS WAS OBSERVED IN THE SUPERIOR CEREBELLAR ARTERY REGION DURING THE PROCEDURE, AND THE EYE NYSTAGMUS COULD BE CAUSED BY THE FLOWN THROMBOSIS. THE EVENT WAS CONSIDERED AS NO CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE ENTERPRISE. THE ISCHEMIA/THROMBOSIS WAS OBSERVED ON INITIAL ANGIOGRAMS DURING THE PROCEDURE, AND THE EVENT WAS TREATED WITH HEPARIN. ANY OTHER TREATMENT WAS NOT DONE AS THE SYMPTOM WAS OBSERVED DURING THE PROCEDURE. THE ISCHEMIA/THROMBOSIS WAS NOT PART OF THE ADMISSION DIAGNOSIS OR PRIOR TO THE PROCEDURE. THERE WAS NO INFORMATION WHEN THE ISCHEMIA/THROMBOSIS OCCURRED OR WHAT PRODUCTS WERE PRESENT WHEN THE EVENT OCCURRED.
IT WAS REPORTED THAT THE VALVE DID NOT WORK AND STARTED TO LEAK.
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. | 13471855 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |