ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
Report
- Report Number
- 3002808486-2016-00551
- Event Type
- Malfunction
- Date Received
- June 21, 2016
- Date of Event
- March 8, 2016
- Report Date
- April 29, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002346960
- PMA / PMN Number
- P140016
- 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 UNDER 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. HOWEVER, IT WAS DETERMINED THAT THE PRODUCT WAS USED OFF LABEL, AS THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS NOT INDICATED FOR TREATMENT OF DISSECTIONS. THIS PRODUCT WAS IN THIS CASE USED FOR TREATMENT OF DISSECTION AS WELL AS ANEURYSM. IT IS NOTED THAT NO NEW CLINICAL EVENT OR INTERVENTION HAS BEEN REPRTED 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.
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. SUMMARY OF INVESTIGATIONAL FINDINGS: THE NEW INFORMATION STATES THAT THE PATIENT DIED ON (B)(6) 2016 FROM THE PREVIOUS DESCRIBED AORTOESOPHAGEAL FISTULA. NO OTHER INFORMATION IS AVAILABLE. AS PREVIOUSLY CONCLUDED THE AORTOESOPHAGEAL FISTULA WAS, ACCORDING TO THE EVENT, CAUSED BY THE INDEX PROCEDURE. ADDITIONALLY, THE ALPHA DEVICE HAS NOT BEEN FORMALLY TESTED IN PATIENT POPULATIONS WITH DISSECTIONS AND IT IS THEREFORE NOT POSSIBLE TO EVALUATE THE PERFORMANCE OF THE DEVICE IN THIS CASE. 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.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. 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.
DESCRIPTION OF EVENT ACCORDING TO STUDY: THIS (B)(6) -YEAR OLD MALE PATIENT IN THE (B)(4) REIMBURSEMENT STUDY HAD A TYPE IB ENDOLEAK NOTED ON THE 1 MO FOLLOW-UP CT. ON (B)(6) 2016, A PROXIMAL COMPONENT (ZTA-P-34-161, LOT # E3340323 ) AND A DISTAL COMPONENT (ZTA-P-34-161, LOT # E3365861) WERE IMPLANTED WITHOUT DIFFICULTY. AN LEFT SUBCLAVIAN ARTERY (LSA) REVASCULARIZATION WAS COMPLETED DURING THE IMPLANT PROCEDURE. THE LSA WAS COVERED COMPLETELY WITH THE PROXIMAL ZONE OF STENT GRAFT IMPLANTATION IN ZONE 2. NO ENDOLEAKS WERE LEFT UNCORRECTED ON THE COMPLETION ANGIOGRAM. THERE WAS ALSO NO EVIDENCE OF FALSE LUMEN PERFUSION. NO SAES HAVE BEEN REPORTED FOR THIS PATIENT. ON (B)(6) 2016 (35 DAYS PP), THE FOLLOW-UP CT WAS PERFORMED AND REVEALED A TYPE IB (DISTAL END) ENDOLEAK. THE SITE NOTED THE LOCATION AS BEING ¿ABOVE DISTAL COMPONENT¿. THERE WAS ALSO EVIDENCE OF FALSE LUMEN PERFUSION FROM DISTAL RE-ENTRY. NO CLINICAL SEQUELAE OR SECONDARY INTERVENTIONS HAVE BEEN REPORTED. PATIENT OUTCOME: ON (B)(6) 2016 (7 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION RECEIVED ON 07JAN2019: ON (B)(6) 2016 THE [PT] DIED FROM PROCEDURE RELATE TO AORTOESOPHAGEAL FISTULA. NO OTHER INFORMATION IS AVAILABLE.
(B)(4). DEVICE SIMILAR TO DEVICE APPROVED UNDER P140016. INVESTIGATION IS STILL IN PROGRESS.
EXEMPTION NUMBER E2016032. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: REINVESTIGATION DUE TO ADDITIONAL INFORMATION PROVIDED. THE INVESTIGATION OF THIS COMPLAINT WAS BASED ON REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORDS AND THE INSTRUCTIONS FOR USE (IFU). A DISSECTION PATIENT WAS TREATED WITH THE USE OF ZENITH ALPHA THORACIC ENDOVASCULAR GRAFTS. 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. IT IS THEREFORE NOT POSSIBLE TO EVALUATE THE PERFORMANCE OF THE DEVICE IN THIS CASE. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
DESCRIPTION OF EVENT ACCORDING TO STUDY: THIS (B)(6) MALE PATIENT IN THE (B)(4) STUDY HAD A TYPE IB ENDOLEAK NOTED ON THE 1 MO FOLLOW-UP CT. ON (B)(6) 2016, A PROXIMAL COMPONENT (ZTA-P-34-161, LOT # E3340323 ) AND A DISTAL COMPONENT (ZTA-P-34-161, LOT # E3365861) WERE IMPLANTED WITHOUT DIFFICULTY. AN LEFT SUBCLAVIAN ARTERY (LSA) REVASCULARIZATION WAS COMPLETED DURING THE IMPLANT PROCEDURE. THE LSA WAS COVERED COMPLETELY WITH THE PROXIMAL ZONE OF STENT GRAFT IMPLANTATION IN ZONE 2. NO ENDOLEAKS WERE LEFT UNCORRECTED ON THE COMPLETION ANGIOGRAM. THERE WAS ALSO NO EVIDENCE OF FALSE LUMEN PERFUSION. NO SAES HAVE BEEN REPORTED FOR THIS PATIENT. ON (B)(6) 2016 (35 DAYS PP), THE FOLLOW-UP CT WAS PERFORMED AND REVEALED A TYPE IB (DISTAL END) ENDOLEAK. THE SITE NOTED THE LOCATION AS BEING "ABOVE DISTAL COMPONENT". THERE WAS ALSO EVIDENCE OF FALSE LUMEN PERFUSION FROM DISTAL RE-ENTRY. NO CLINICAL SEQUELAE OR SECONDARY INTERVENTIONS HAVE BEEN REPORTED. PATIENT OUTCOME: ON (B)(6) 2016 (7 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. PATIENT OUTCOME: ON (B)(6) 2016 (7 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.
ADDITIONAL INFORMATION RECEIVED 08AUG2017: ON (B)(6) 2016 (147 DAYS PP), THE PATIENT WAS NOTED TO HAVE AN AORTOESOPHAGEAL FISTULA WHICH WAS CONSIDERED RELATED TO THE INDEX PROCEDURE, BUT NOT RELATED TO THE STUDY DEVICE. THE PATIENT WAS TREATED WITH MEDICATION AND TRANSFUSION. NO SECONDARY INTERVENTION HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 393593 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3340323 | 10827002346960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Life Threatening |