ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2017-04293
- Event Type
- Injury
- Date Received
- December 19, 2017
- Date of Event
- October 24, 2014
- Report Date
- June 21, 2018
- Manufacturer
- COOK INC
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
THE USER FACILITY REPORTED PATIENT FROM PROTOCOL 12-010 IN WHICH AN ADVERSE EVENT OCCURRED; THROMBUS IN WHOLE ENDOGRAFT REQUIRING INTERVENTIONAL SURGERY/REMOVAL. ON (B)(6) 2014, THE ELECTIVELY SELECTED PATIENT WITH AN ASYMPTOMATIC ANEURYSM WITH MAXIMUM DIAMETER > 5 CM, WHICH REQUIRED PLACEMENT OF ENDOVASCULAR STENT GRAFT, UNDERWENT A PROCEDURE AND HAD THREE COOK DEVICES IMPLANTED, A ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY, BELOW RENAL, A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (LEFT) IN COMMON ILIAC, AND A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RIGHT) IN COMMON ILIAC. ON THE DAY OF PROCEDURE, THE PATIENT PRESENTED WITH A MAXIMUM ANEURYSM DIAMETER OF 72 MM AND A PROXIMAL NECK DIAMETER AT LOWEST RENAL ARTERY WAS 20 MM. THE NECK QUALITY WAS CLASSIFIED AS PARALLEL AND IT WAS MARKED AS PARTIAL REGARDING LOCATION OF PLAQUE/THROMBUS. THE PROCEDURAL IMAGING REVEALED PATENT DEVICES AT THE CONCLUSION OF THE PROCEDURE AND NO KINKS OR ENDOLEAKS WERE OBSERVED. THE PROCEDURE WAS CONSIDERED TO BE SUCCESSFUL. A PLANNED FEM-FEM BYPASS, AN UNPLANNED RIGHT ILIAC ANGIOPLASTY, AN UNPLANNED RIGHT ILIAC ARTERY STENT (COVERED) IN GRAFT LIMB AND AN UNPLANNED RIGHT ILIAC ARTERY STENT (UNCOVERED) IN NATIVE VESSEL WAS PERFORMED AS ADDITIONAL PROCEDURE. ON (B)(6) 2014 (94 DAYS POST-PROCEDURE), THE SIX-MONTH FOLLOW-UP WAS PERFORMED. THE IMAGING REVEALED A MAXIMUM ANEURYSM DIAMETER OF 67 MM. DIAMETER OF RIGHT ILIAC WAS 17 MM AND LEFT ILIAC WAS OCCLUDED WITH COMPLETE LOSS OF PATENCY. AN ENDOLEAK TYPE 2 WAS OBSERVED. THE DEVICES WERE INTACT AND THERE WAS NO MIGRATION OR KINK OBSERVED. THROMBUS WAS OBSERVED ON THE IMAGING. A THROMBECTOMY AND FEMORO-FEMORAL BY-PASS WAS DONE. THE REPORTER CONSIDERED THIS EVENT RELATED TO THE DEVICE. THE EVENT WAS RESOLVED ON (B)(6) 2014. ON (B)(6) 2015 (206 DAYS POST-PROCEDURE), THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO A THROMBUS IN THE WHOLE ENDOGRAFT AND BOTH ILIAC LEGS. THE TREATMENT WAS THROMBECTOMY OF THE MAIN BODY AND BOTH LEG GRAFTS. ADDITIONALLY, THE FEM-FEM BYPASS WAS REMOVED. THIS EVENT WAS CONSIDERED PROBABLY RELATED TO PROCEDURE AND UNLIKELY RELATED TO DEVICE. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2015. ON (B)(6) 2015 (234 DAYS POST-PROCEDURE), THE 12-MONTH FOLLOW-UP WAS PERFORMED. THE IMAGING REVEALED A MAXIMUM ANEURYSM DIAMETER OF 65 MM. THE DEVICES WERE PATENT AND INTACT AND THERE WAS NO MIGRATION, KINK OR ENDOLEAK OBSERVED. THERE WAS STILL EVIDENCE OF DEVICE STENOSIS IN THE LEFT ILIAC LEG. THE DIAMETER OF THE RIGHT ILIAC WAS 10 MM AND THE DIAMETER OF LEFT ILIAC WAS 8 MM. ON (B)(6) 2015 (248 DAYS POST-PROCEDURE), A DISSECTION IN THE LEFT ILIAC LEG WAS OBSERVED. THIS WAS TREATED WITH PLACEMENT OF A STENT ON (B)(6) 2015. THAT PROCEDURE WAS CONSIDERED SUCCESSFUL. ON (B)(6) 2016 (563 DAYS POST-PROCEDURE), THE 2-YEAR FOLLOW-UP WAS PERFORMED. THE IMAGING REVEALED A MAXIMUM ANEURYSM DIAMETER OF 65 MM. THE DEVICES WERE PATENT WITHOUT EVIDENCE OF STENOSIS AND THEY WERE INTACT AND THERE WAS NO MIGRATION OR KINK OBSERVED. ON (B)(6) 2017 (948 DAYS POST-PROCEDURE), THE 3-YEAR FOLLOW-UP WAS PERFORMED. THE IMAGING REVEALED A MAXIMUM ANEURYSM DIAMETER OF 63 MM. THE DEVICES WERE PATENT WITHOUT EVIDENCE OF STENOSIS AND THEY WERE INTACT AND THERE WAS NO MIGRATION OR KINK OBSERVED. ON (B)(6) 2018 (1309 DAYS POST-PROCEDURE), THE PATIENT DIED OF UNKNOWN REASONS. NO AUTOPSY WAS DONE AND NO DEATH REPORT IS AVAILABLE. THE PATIENT DID HAVE A ZENITH AAA STENT GRAFT AT THE TIME OF DEATH. TWO SEPARATE RELATED REPORTS ARE BEING FILED FOR THROMBUS WHICH OCCURRED IN BOTH OF THE ILIAC LEGS LEADING TO A SECONDARY INTERVENTION REQUIRING THROMBECTOMY AND REMOVAL OF THE ENDOGRAFTS. ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (LEFT) (CATALOG # ZSLE-20-56-ZT) MFR REPORT # 1820334-2017-04287. ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RIGHT) (CATALOG # ZSLE-9-90-ZT) MFR INITIAL REPORT. A REPORT IS NOT BEING FILED FOR THROMBUS IN THE ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (CATALOG # ZALB-24-128) AS THIS DEVICE IS NOT SOLD IN U.S. AND THERE IS NOT A SIMILAR DEVICE MANUFACTURED BY COOK INC. THAT IS MARKETED IN THE U.S.
EVALUATION / INVESTIGATION: THE ACTUAL COMPLAINT DEVICE WAS NOT RETURNED. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. NO IMAGING WAS PROVIDED FOR REVIEW. A REVIEW OF THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL DATA WAS CONDUCTED. THE FOCUS OF THE COMPLAINT IS A RIGHT ZSLE-9-90-ZT THAT WAS IMPLANTED ON (B)(6) 2014 TO TREAT AN ASYMPTOMATIC ANEURYSM THAT WAS LARGER THAN 5 CM. THE PATIENT WAS CONSIDERED TO BE A HIGH RISK WITH A MEDICAL HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, DIABETES, LOWER LIMB OBLITERATING ARTERIOPATHY, AND IS A CURRENT SMOKER. ON (B)(6) 2015, THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO A THROMBUS IN THE MAIN BODY AND BOTH LEG EXTENSIONS. A THROMBECTOMY AND DEVICE REMOVAL WAS PERFORMED. AS STATED BY THE REPORTER, ¿THIS EVENT WAS PROBABLY RELATED TO THE PROCEDURE AND UNLIKELY RELATED TO THE DEVICE.¿ THERE DOES NOT APPEAR TO BE ANY EVIDENCE THE ZSLE-9-90-ZT WAS CAUSALLY RELATED TO THE THROMBUS IN THE LEFT ILIAC. THERE IS NO INFORMATION REGARDING ANY OCCLUSION OR DEVICE MALFUNCTION OF THE ZSLE-9-90-ZT. PER THE 12-MONTH AND 3-YEAR FOLLOW UP REPORTS POST IMPLANTATION, THE DEVICE WAS ¿PATENT AND INTACT AND THERE WAS NO MIGRATION, KINK OR ENDOLEAK OBSERVED. IT SHOULD BE NOTED THERE IS NO INFORMATION REGARDING HUMAN ANATOMICAL FEATURES THAT MAY HAVE IMPACTED THIS EVENT. PER THE INSTRUCTIONS FOR USE (IFU), VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. THE PATIENT HAS A HISTORY OF CORONARY LESIONS WHICH IN TURN INCREASES THE RISK OF BLOOD CLOTS IN THE ARTERIES DUE TO PLAQUE RUPTURE AND THE FORMATION OF BLOOD CLOTS. PER THE INSTRUCTIONS FOR USE (IFU), PATIENTS WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE (E.G., CANCER) MAY BE AT INCREASED RISK OF A THROMBOEMBOLIC EVENT. THE PATIENT¿S MEDICAL CONDITIONS OF HYPERLIPIDEMIA AND HYPERTENSION ALSO INCREASE THIS RISK. ON (B)(6) 2018, IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. THE DATE OF DEATH IS NOT KNOWN. THE CAUSE OF DEATH IS NOT KNOWN. THERE IS NO AUTOPSY REPORT OR DEATH CERTIFICATE FOR REVIEW. THERE ARE NO MEDICAL RECORDS FOR REVIEW. THE INFORMATION DOES NOT SUGGEST THERE WAS ANY CAUSAL RELATIONSHIP BETWEEN THE PATIENT¿S DEATH AND THE ZSLE-20-56-ZT. THE DEVICE HISTORY RECORDS FOR THE DEVICE WERE NOT ABLE TO BE REVIEWED AS THE LOT INFORMATION WAS NOT PROVIDED. THROMBOSIS CAN OCCUR FOR A VARIETY OF REASONS, SUCH AS A PATIENT WITH A HYPERCOAGULABLE STATE, TORTUOUS OR NARROW VESSELS, PRE-EXISTING THROMBUS, CALCIFICATION, GRAFT IN-FOLDING, OR ANY OTHER MECHANISM THAT CAUSES A LUMEN REDUCTION WITHIN THE STENT GRAFT. ACCORDING TO THE INSTRUCTIONS FOR USE: VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. PRE-EXISTING REGIONS OF STENOSIS/NARROWING HAVE BEEN SHOWN TO INCREASE THE RISK OF A THROMBOEMBOLIC EVENT (E.G., GRAFT LIMB OCCLUSION). PATIENTS WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE (E.G., CANCER) MAY BE AT AN INCREASED RISK OF THROMBOEMBOLIC EVENT. BASED ON THE AVAILABLE INFORMATION A CONTRIBUTING CAUSE TO THE REPORTED FAILURE MODE ¿OCCLUSION¿ IS PROCEDURE RELATED; PATIENT¿S CONDITION RELATED TO OCCURRENCE, DUE TO THE PRE-EXISTING CONDITIONS OF SYSTEMIC DISEASE, PARTIAL THROMBUS OR PLAQUE IN THE NECK AND THE PATIENT BEING A SMOKER. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. THE APPROPRIATE COOK PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT.
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.
IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. THE DATE OF DEATH IS NOT KNOWN. THE CAUSE OF DEATH IS NOT KNOWN. THERE IS NO AUTOPSY REPORT OR DEATH CERTIFICATE FOR REVIEW. THERE ARE NO MEDICAL RECORDS FOR REVIEW.
THE USER FACILITY REPORTED PATIENT FROM PROTOCOL (B)(4) IN WHICH AN ADVERSE EVENT OCCURRED; THROMBUS IN WHOLE ENDOGRAFT REQUIRING INTERVENTIONAL SURGERY/REMOVAL. ON (B)(6) 2014, THE ELECTIVELY SELECTED PATIENT WITH AN ASYMPTOMATIC ANEURYSM WITH MAXIMUM DIAMETER > 5 CM, WHICH REQUIRED PLACEMENT OF ENDOVASCULAR STENT GRAFT, UNDERWENT A PROCEDURE AND HAD THREE COOK DEVICES IMPLANTED, A ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY, BELOW RENAL, A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (LEFT) IN COMMON ILIAC, AND A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RIGHT) IN COMMON ILIAC. ON THE DAY OF PROCEDURE, THE PATIENT PRESENTED WITH A MAXIMUM ANEURYSM DIAMETER OF 72 MM AND A PROXIMAL NECK DIAMETER AT LOWEST RENAL ARTERY WAS 20 MM. THE NECK QUALITY WAS CLASSIFIED AS PARALLEL AND IT WAS MARKED AS PARTIAL REGARDING LOCATION OF PLAQUE/THROMBUS. THE PROCEDURAL IMAGING REVEALED PATENT DEVICES AT THE CONCLUSION OF THE PROCEDURE AND NO KINKS OR ENDOLEAKS WERE OBSERVED. THE PROCEDURE WAS CONSIDERED TO BE SUCCESSFUL. A PLANNED FEM-FEM BYPASS, AN UNPLANNED RIGHT ILIAC ANGIOPLASTY, AN UNPLANNED RIGHT ILIAC ARTERY STENT (COVERED) IN GRAFT LIMB AND AN UNPLANNED RIGHT ILIAC ARTERY STENT (UNCOVERED) IN NATIVE VESSEL WAS PERFORMED AS ADDITIONAL PROCEDURE. ON (B)(6) 2014 (94 DAYS POST-PROCEDURE), THE SIX-MONTH FOLLOW-UP WAS PERFORMED. THE IMAGING REVEALED A MAXIMUM ANEURYSM DIAMETER OF 67 MM. DIAMETER OF RIGHT ILIAC WAS 17 MM AND LEFT ILIAC WAS OCCLUDED WITH COMPLETE LOSS OF PATENCY. AN ENDOLEAK TYPE 2 WAS OBSERVED. THE DEVICES WERE INTACT AND THERE WAS NO MIGRATION OR KINK OBSERVED. ON (B)(6) 2015 (206 DAYS POST-PROCEDURE), THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO A THROMBUS IN THE WHOLE ENDOGRAFT AND BOTH ILIAC LEGS. THE TREATMENT WAS THROMBECTOMY AND DEVICE REMOVAL. THIS SECONDARY INTERVENTION WAS CONSIDERED SUCCESSFUL. A QUERY HAS BEEN SUBMITTED AND NOT YET RECEIVED TO FIND OUT WHAT PART OF THE DEVICE WAS REMOVED. THIS EVENT WAS CONSIDERED PROBABLY RELATED TO PROCEDURE AND UNLIKELY RELATED TO DEVICE. ON (B)(6) 2015 (234 DAYS POST-PROCEDURE), THE 12-MONTH FOLLOW-UP WAS PERFORMED. THE IMAGING REVEALED A MAXIMUM ANEURYSM DIAMETER OF 65 MM. THE DEVICES WERE PATENT AND INTACT AND THERE WAS NO MIGRATION, KINK OR ENDOLEAK OBSERVED. THERE WAS STILL EVIDENCE OF DEVICE STENOSIS IN THE LEFT ILIAC LEG. THE DIAMETER OF THE RIGHT ILIAC WAS 10 MM AND THE DIAMETER OF LEFT ILIAC WAS 8 MM. ON (B)(6) 2016 (563 DAYS POST-PROCEDURE), THE 2-YEAR FOLLOW-UP WAS PERFORMED. THE IMAGING REVEALED A MAXIMUM ANEURYSM DIAMETER OF 65 MM. THE DEVICES WERE PATENT WITHOUT EVIDENCE OF STENOSIS AND THEY WERE INTACT AND THERE WAS NO MIGRATION OR KINK OBSERVED. ON (B)(6) 2017 (948 DAYS POST-PROCEDURE), THE 3-YEAR FOLLOW-UP WAS PERFORMED. THE IMAGING REVEALED A MAXIMUM ANEURYSM DIAMETER OF 63 MM. THE DEVICES WERE PATENT WITHOUT EVIDENCE OF STENOSIS AND THEY WERE INTACT AND THERE WAS NO MIGRATION OR KINK OBSERVED. REPORTS ARE BEING FILED FOR THROMBUS IN BOTH ILIAC LEGS WHICH LED TO A SECONDARY INTERVENTION REQUIRING THROMBECTOMY AND REMOVAL OF THE ENDOGRAFTS: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (LEFT) (CATALOG # ZSLE-20-56-ZT) REMOVAL IS CAPTURED IN MANUFACTURER REPORT # 1820334-2017-04287. ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RIGHT) (CATALOG # ZSLE-9-90-ZT) REMOVAL IS CAPTURED IN THIS REPORT. A REPORT IS NOT BEING FILED FOR THROMBUS IN THE ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (CATALOG # ZALB-24-128) AS THIS DEVICE IS NOT SOLD IN US AND THERE IS NOT A SIMILAR DEVICE MANUFACTURED BY COOK INC. THAT IS MARKETED IN THE US. THE PATIENT REMAINED IN THE STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 907315 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |