ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
Report
- Report Number
- 3002808486-2017-01801
- Event Type
- Death
- Date Received
- September 12, 2017
- Date of Event
- March 8, 2017
- Report Date
- August 13, 2018
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002346793
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
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. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE COMPLAINT WAS REOPENED SINCE PREOPERATIVE CT IMAGES WAS RECEIVED. THE FINDINGS IN THE NEW IMAGING REVIEW DO NOT CHANGE THE PREVIOUSLY SUBMITTED INVESTIGATION FROM 23NOV2017. PREOPERATIVE CT IMAGES WERE PROVIDED AND REVIEWED FOR NEW INFORMATION. THE REVIEW OF THE IMAGES DEMONSTRATES HOW THE 26MM ZTA DEVICE IS OVERSIZED COMPARED TO PATIENT ANATOMY (REFER TO IFU). THE REVIEW STATES THAT THE AORTIC DIAMETER AT THE LCCA WAS 19.2 X 19.2 MM AND JUST PROXIMAL TO THE INJURY 17.3 X 17.8 MM. THE AORTIC DIAMETER JUST DISTAL TO THE INJURY WAS 16.7 X 16.8 MM AND THE DISTAL SEALING ZONE WAS 18.5 X 19.5 MM. THIS OVERSIZING MAY ALSO BE A CONTRIBUTING FACTOR LEADING TO THE THROMBOSIS EVENT. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
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. (B)(4). SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
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.
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. SUMMARY OF INVESTIGATIONAL FINDINGS: ACCORDING TO IMAGING REVIEW THERE IS COMPLETE THROMBOSIS OF THE ZTA THORACIC STENT GRAFT DEVICE. THIS IS SUCCESSFULLY RE-LINED WITH A NEW THORACIC STENT GRAFT WITH RESTORATION OF FLOW THROUGH THIS SEGMENT. ON THE INITIAL IMAGING, THERE APPEARS TO BE SLIGHT INWARD IMPINGEMENT OF THE 2ND STENT RING INTO THE ZTA DEVICE LUMEN DUE TO TELESCOPING ALONG THE LESSER CURVE. THIS LIKELY WOULD NOT CAUSE SIGNIFICANT LUMINAL NARROWING, BUT THIS IS THE SAME LEVEL WHERE THE THROMBOSIS APPEARS TO ORIGINATE. THE NEWLY PLACED DEVICE ALSO SHOWS SLIGHT NARROWING AT THIS LEVEL. THE THROMBOSIS IS LIKELY RELATED TO THE CLINICAL PERFORMANCE OF THE ZTA DEVICE. HOWEVER, APPROPRIATE SIZING AND USE OF THE DEVICE CANNOT BE ASSESSED WITHOUT PREOPERATIVE IMAGING AND THE EXACT CAUSE OF THROMBOSIS CANNOT BE DEFINITIVELY DETERMINED FROM THE IMAGING PROVIDED. AS PER IFU ARTERIAL THROMBOSIS AND CLAUDICATION ARE KNOWN POTENTIAL ADVERSE EVENTS. THE IFU HAS BEEN UPDATED SINCE BTAI INDICATION HAS BEEN REMOVED. FROM THE PRODUCT LABELING THIS DEVICE WAS IMPLANTED PRIOR TO THE IFU UPDATE IN JUNE 2017. 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 INITIAL REPORTER: WE HAD A CASE OF TRANSECTION AORTIC LAST YEAR AND PLACED A ZENITH ALPHA THORACIC ZTA-P-26-105 WITH LOT: E3239477. THE PATIENT CAME BACK TO THE HOSPITAL ONE YEAR AFTER WITH CHEST PAIN AND THE GRAFT WAS THROMBOSED. THE PHYSICIANS TRIED TO PLACE ANOTHER GRAFT INTO THE ALPHA BUT IT WAS IMPOSSIBLE AND THE PATIENT DIED. PATIENT OUTCOME: PATIENT DIED.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WE HAD A CASE OF TRANSECTION AORTIC LAST YEAR AND PLACED A ZENITH APHA THORACIC ZTA-P-26-105 WITH LOT: E3239477. THE PATIENT CAME BACK TO THE HOSPITAL ONE YEAR AFTER WITH CHEST PAIN AND THE GRAFT WAS THROMBOSED. THE PHYSICIANS TRIED TO PLACE ANOTHER GRAFT INTO THE ALPHA BUT IT WAS IMPOSSIBLE AND THE PATIENT DIED. PATIENT OUTCOME: PATIENT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 637197 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3239477 | 10827002346793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |