ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
Report
- Report Number
- 9680654-2019-00023
- Event Type
- Injury
- Date Received
- June 25, 2019
- Date of Event
- August 23, 2018
- Report Date
- August 13, 2019
- Manufacturer
- WILLIAM A. COOK AUSTRALIA, PTY LTD
- Product Code
- MIH
- UDI-DI
- 10827002381664
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
THE DEVICE WAS NOT RETURNED FOR EVALUATION. WORK ORDER (B)(4) WAS REVIEWED AND APPEARS COMPLETE AND CORRECT. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION AND MEDICAL IMAGING REGARDING THIS CASE. HOWEVER, NO INFORMATION HAS BEEN RECEIVED. THE DEVICE IFU STATES: "THE LONG-TERM PERFORMANCE AND SAFETY OF ENDOVASCULAR GRAFTS HAS NOT YET BEEN ESTABLISHED. AS A RESULT, LIFE-LONG, REGULAR FOLLOW-UP MUST BE UNDERTAKEN IN ALL PATIENTS TO ASSESS THE ONGOING PERFORMANCE OF THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED FOLLOW-UP." "INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. RENAL ARTERY PATENCY MUST BE MAINTAINED TO PREVENT/REDUCE THE RISK OF RENAL FAILURE AND SUBSEQUENT COMPLICATIONS." "UNLESS MEDICALLY INDICATED, DO NOT DEPLOY THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT IN A LOCATION THAT WILL OCCLUDE ARTERIES NECESSARY TO SUPPLY BLOOD FLOW TO ORGANS OR EXTREMITIES. DO NOT COVER SIGNIFICANT RENAL OR MESENTERIC ARTERIES WITH THE ENDOPROSTHESIS. VESSEL OCCLUSION MAY OCCUR. CLINICAL STUDIES HAVE IDENTIFIED THAT WITH USE OF THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT THERE IS A RISK OF RENAL IMPAIRMENT/LOSS (WHICH COULD LEAD TO A NEED FOR DIALYSIS). CLINICAL STUDIES HAVE SHOWN THAT THIS RISK IS REDUCED WHEN THE RENAL ARTERIES ARE STENTED AS PART OF THE PROCEDURE TO IMPLANT A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT. STENTING OF THE RENAL ARTERIES IS THEREFORE STRONGLY RECOMMENDED WITH USE OF THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT TO REDUCE THE RISK OF RENAL IMPAIRMENT/LOSS." BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT A DEVICE NON-CONFORMANCE OR DEFICIENCY CONTRIBUTED TO THE COMPLAINT. IT IS POSSIBLE THAT ONE OR MORE OF THE FOLLOWING FACTOR CONTRIBUTED TO THE COMPLAINT: GRAFT IS PRONE TO THROMBUS FORMATION, PATIENT FACTORS, PROCEDURAL FACTORS.
4 DEVICES WERE IMPLANTED ON (B)(6) 2018. THE PROCEDURE INFORMATION STATES THAT THE LEFT RENAL ARTERY COULD NOT BE CANNULATED SO A CHIMNEY GRAFT WAS IMPLANTED TO MAINTAIN BLOOD SUPPLY TO THE LEFT RENAL ARTERY. ADDITIONALLY, THE INFORMATION INDICATES THE FENESTRATED GRAFT WAS DEPLOYED IN THE INTENDED LOCATION, NO TYPE I OR III ENDOLEAKS, NO DEVICE INTEGRITY ISSUES, AND NO CONVERSION TO OPEN REPAIR.
4 DEVICES WERE IMPLANTED ON (B)(6) 2018. THE PROCEDURE INFORMATION STATES THAT THE LEFT RENAL ARTERY COULD NOT BE CANNULATED SO A CHIMNEY GRAFT WAS IMPLANTED TO MAINTAIN BLOOD SUPPLY TO THE LEFT RENAL ARTERY. ADDITIONALLY, THE INFORMATION INDICATES THE FENESTRATED GRAFT WAS DEPLOYED IN THE INTENDED LOCATION, NO TYPE I OR III ENDOLEAKS, NO DEVICE INTEGRITY ISSUES, AND NO CONVERSION TO OPEN REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 526522 | ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM A. COOK AUSTRALIA, PTY LTD | AC1019926 | 10827002381664 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention | ZFEN-D-12-45-76 TFLE-12-73-ZT TFLE-18-73-ZT| ZFEN-D-12-45-76 TFLE-12-73-ZT TFLE-18-73-ZT| ZFEN-D-12-45-76 TFLE-12-73-ZT TFLE-18-73-ZT |