ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
Report
- Report Number
- 3002808486-2016-00251
- Event Type
- Malfunction
- Date Received
- May 6, 2016
- Date of Event
- December 10, 2015
- Report Date
- April 26, 2018
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE WITK 510(K): P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE WITH 510(K): P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION OF THIS COMPLAINT WAS ONLY BASED ON THE INFORMATION PROVIDED IN THIS COMPLAINT FILE ALONG WITH THE DEVICE HISTORY RECORD AND THE IFU. IT WAS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED EVENT BASED ON THE INFORMATION CURRENTLY AVAILABLE. ACCORDING TO THE IFU: - THE PROXIMAL COMPONENT SHOULD BE USED IN COMBINATION WITH A DISTAL COMPONENT, AS THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS A TWO-PIECE CYLINDRICAL ENDOVASCULAR GRAFT CONSISTING OF PROXIMAL AND DISTAL COMPONENTS - ENDOLEAK IS A KNOWN ADVERSE EVENT. IT IS NOTED THAT NO NEW CLINICAL EVENT OR INTERVENTION HAS BEEN REPORTED DUE TO THE ENDOLEAK. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. THE COMPLAINT WILL BE CLOSED, AND REOPENED IF NEW INFORMATION IS PROVIDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
DESCRIPTION ACCORDING TO STUDY: THIS (B)(6) FEMALE PATIENT IN THE FRENCH REIMBURSEMENT STUDY HAD A TYPE IB ENDOLEAK NOTED ON A FOLLOW-UP CT (3 DAYS POST-PROCEDURE). ON (B)(6) 2015, A PROXIMAL COMPONENT (ZTA-P-28-201, LOT # UNKNOWN) WAS IMPLANTED WITHOUT DIFFICULTY. THE LEFT SUBCLAVIAN ARTERY (LSA) WAS COVERED WITH THE PROXIMAL ZONE OF STENT GRAFT IMPLANTATION BEING IN ZONE 2. REVASCULARIZATION OF THE LSA WAS COMPLETED PRIOR TO THE IMPLANT PROCEDURE. ON THE FINAL COMPLETION ANGIOGRAM, THERE WAS NO EVIDENCE OF AN UNCORRECTED ENDOLEAK. ON (B)(6) 2015 (3 DAYS PP), A FOLLOW-UP CT SHOWED A TYPE IB (DISTAL END) ENDOLEAK WHICH HAD NOT BEEN PRESENT ON THE PREVIOUS FILM READ. THIS DID NOT RESULT IN A NEW CLINICAL EVENT OR INTERVENTION. ADDITIONAL INFORMATION RECEIVED 21MAR2017: THE INVESTIGATIVE SITE CHANGED THEIR ASSESSMENT OF THE POST-PROCEDURE CT SCAN AND NOTED THAT THERE WAS NO ENDOLEAK 3 DAYS POST-PROCEDURE. PATIENT OUTCOME: ON (B)(6) 2015 (6 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO FURTHER INFORMATION HAS BEEN RECEIVED.
DESCRIPTION ACCORDING TO STUDY: THIS (B)(6) FEMALE PATIENT IN THE (B)(6) STUDY HAD A TYPE IB ENDOLEAK NOTED ON A FOLLOW-UP CT (3 DAYS POST-PROCEDURE). ON (B)(6) 2015, A PROXIMAL COMPONENT (ZTA-P-28-201, LOT # UNKNOWN) WAS IMPLANTED WITHOUT DIFFICULTY. THE LEFT SUBCLAVIAN ARTERY (LSA) WAS COVERED WITH THE PROXIMAL ZONE OF STENT GRAFT IMPLANTATION BEING IN ZONE 2. REVASCULARIZATION OF THE LSA WAS COMPLETED PRIOR TO THE IMPLANT PROCEDURE. ON THE FINAL COMPLETION ANGIOGRAM, THERE WAS NO EVIDENCE OF AN UNCORRECTED ENDOLEAK. ON (B)(6) 2015 (3 DAYS PP), A FOLLOW-UP CT SHOWED A TYPE IB (DISTAL END) ENDOLEAK WHICH HAD NOT BEEN PRESENT ON THE PREVIOUS FILM READ. THIS DID NOT RESULT IN A NEW CLINICAL EVENT OR INTERVENTION. ADDITIONAL INFORMATION RECEIVED 21MAR2017: THE INVESTIGATIVE SITE CHANGED THEIR ASSESSMENT OF THE POST-PROCEDURE CT SCAN AND NOTED THAT THERE WAS NO ENDOLEAK 3 DAYS POST-PROCEDURE. PATIENT OUTCOME: ON (B)(6) 2015 (6 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO FURTHER INFORMATION HAS BEEN RECEIVED.
(B)(4). SIMILAR TO DEVICE WITH 510(K) P140016. INVESTIGATION IS STILL IN PROGRESS.
EXEMPTION NUMBER E2016032. (B)(4). MANUFACTURER REF# (B)(4). THE EVENT IS NO LONGER CONSIDERED REPORTABLE AS REVIEW OF THE PROVIDED IMAGING DID NOT CONFIRM THE REPORTED EVENT, TYPE IB ENDOLEAK BECAUSE CONTRAST NEVER EXTENDED BETWEEN THE ENDOGRAFT AND THE INTIMA. RETROGRADE SAC PERFUSION SUPPLIED BY INTIMAL DEFECTS INFERIOR TO ENDOGRAFT, PRESENT UNTIL ONE YEAR POST IMPLANTATION, PRESUMABLY WAS MISINTERPRETED AS A TYPE IB ENDOLEAK. THEREFORE, THERE WAS NO MALFUNCTION OF THE DEVICE AND THE EVENT DID NOT LEAD TO SERIOUS INJURY OR DEATH OF THE PATIENT. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE INCIDENT WAS RE-INVESTIGATED DUE TO IMAGING RECIEVED 22JAN2018. THE INVESTIGATION IS BASED ON REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORDS AND THE INSTRUCTIONS FOR USE (IFU) AS WELL AS IMAGING. THE REVIEW OF THE PROVIDED IMAGING DID NOT CONFIRM THE REPORTED EVENT, TYPE IB ENDOLEAK BECAUSE CONTRAST NEVER EXTENDED BETWEEN THE ENDOGRAFT AND THE INTIMA. RETROGRADE SAC PERFUSION SUPPLIED BY INTIMAL DEFECTS INFERIOR TO ENDOGRAFT, PRESENT UNTIL ONE YEAR POST IMPLANTATION, PRESUMABLY WAS MISINTERPRETED AS A TYPE IB ENDOLEAK. MOREOVER, THE DEVICE WAS USED OUTSIDE OF INTENDED USE, AS THE LESION WAS A CHRONIC TYPE B DISSECTION RATHER THAN AN ANEURYSM. AS PER IFU, THE ALPHA GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSMS/ULCERS OF THE DESCENDING THORACIC AORTA AND HAS NOT BEEN FORMALLY TESTED IN PATIENT POPULATIONS WITH DISSECTIONS. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
DESCRIPTION ACCORDING TO STUDY: THIS (B)(6) FEMALE PATIENT IN THE (B)(6) STUDY HAD A TYPE IB ENDOLEAK NOTED ON A FOLLOW-UP CT (3 DAYS POST-PROCEDURE). ON (B)(6) 2015, A PROXIMAL COMPONENT (ZTA-P-28-201, LOT # UNKNOWN) WAS IMPLANTED WITHOUT DIFFICULTY. THE LEFT SUBCLAVIAN ARTERY (LSA) WAS COVERED WITH THE PROXIMAL ZONE OF STENT GRAFT IMPLANTATION BEING IN ZONE 2. REVASCULARIZATION OF THE LSA WAS COMPLETED PRIOR TO THE IMPLANT PROCEDURE. ON THE FINAL COMPLETION ANGIOGRAM, THERE WAS NO EVIDENCE OF AN UNCORRECTED ENDOLEAK. ON (B)(6) 2015 (3 DAYS PP), A FOLLOW-UP CT SHOWED A TYPE IB (DISTAL END) ENDOLEAK WHICH HAD NOT BEEN PRESENT ON THE PREVIOUS FILM READ. THIS DID NOT RESULT IN A NEW CLINICAL EVENT OR INTERVENTION. PATIENT OUTCOME: ON (B)(6) 2015 (6 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO FURTHER INFORMATION HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293086 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |