ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2024-01386
- Event Type
- Injury
- Date Received
- October 22, 2024
- Date of Event
- July 9, 2024
- Report Date
- October 21, 2025
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002552378
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: B5. CORRECTION: H6 (ANNEX E). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
ADDITIONAL INFORMATION WAS PROVIDED ON 16DEC2024. THE CUSTOMER INDICATED INITIALLY THERE WAS A RIGHT ILIAC RUPTURE REQUIRING HYPOGASTRIC EMBOLIZATION AND AN ILIAC ENDOCONDUIT. POSTOPERATIVELY AN ILIAC OCCLUSION OCCURRED.
IT WAS REPORTED TO COOK THAT THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG PLACED ON THE PATIENT'S RIGHT SIDE OCCLUDED. A PRE-PROCEDURAL COMPUTED TOMOGRAPHY (CT) WITH CONTRAST IMAGING WAS COMPLETED ON (B)(6)2024, 105 DAYS PRIOR TO THE PROCEDURE TO PLAN FOR A CUSTOM-MADE DEVICE. THE PRIMARY INDICATION WAS AN AORTIC DEGENERATIVE ANEURYSM. THERE WAS A HISTORY OF ANEURYSM GROWTH MORE THAN 1.0 CM PER YEAR. THE INNOMINATE ARTERY, RIGHT COMMON CAROTID ARTERY, RIGHT SUBCLAVIAN ARTERY, LEFT COMMON CAROTID ARTERY, LEFT SUBCLAVIAN ARTERY, CELIAC ARTERY, AND SUPERIOR MESENTERIC ARTERY WERE INCORPORATED INTO THE REPAIR. ALL ARTERIES MENTIONED WERE PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE RIGHT RENAL ARTERY WAS INCORPORATED INTO THE REPAIR AND WAS PATENT. HOWEVER, STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE LEFT RENAL ARTERY WAS INCORPORATED INTO THE REPAIR AND WAS PATENT. HOWEVER, STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE RIGHT AND LEFT COMMON ILIAC ARTERIES WERE PATENT. THE RIGHT AND LEFT INTERNAL ILIAC ARTERIES WERE PATENT. THE AORTIC VALVE WAS NATIVE. THE MAXIMUM DIAMETER OF THE DISEASED AORTA ON CENTERLINE WAS 53 MM THE METHOD OF LENGTH MEASUREMENT WAS CENTERLINE. THE INTENDED PROXIMAL SEAL ZONE, ZONE 5: MID DESCENDING AORTA TO CELIAC THE LEFT AND RIGHT INTENDED DISTAL LANDING ZONE WAS ZONE 10: COMMON ILIAC ARTERIES. ON (B)(6) 2024 THE PATIENT UNDERWENT A FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) PROCEDURE UNDER GENERAL ANESTHESIA. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA) AT THE TIME OF THE PROCEDURE. PERCUTANEOUS ACCESS WAS ACHIEVED IN THE LEFT AND RIGHT FEMORAL ARTERIES. SIDE BRANCH CATHETERIZATION AND PLACEMENT OF ALL BRIDGING STENTS WAS SUCCESSFUL. DURING THE CUSTOM-MADE DEVICE (CMD) PROCEDURE IT WAS PLANNED TO PERFORM ANGIOPLASTY ON THE RIGHT AND LEFT ILIAC ARTERIES. UNPLANNED PROCEDURES COMPLETED DURING THE CMD PROCEDURE INCLUDED AN ENDOVASCULAR ILIAC CONDUIT AND EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY (IMA) DUE TO RUPTURE OF THE RIGHT ILIAC ARTERY. DURING THE PROCEDURE, THE PATIENT HAD THE FOLLOWING STENTS PLACED: CELIAC ARTERY: A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 17 MM IN LENGTH WAS PLACED. THE ARTERY WAS ABLE TO BE REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENT WAS NOT RELINED OR EXTENDED WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENT WAS SUCCESSFUL. THE STENT PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. SUPERIOR MESENTERIC ARTERY (SMA): A COMPETITOR'S STENT MEASURING 10 MM IN DIAMETER AND 27 MM LENGTH WAS PLACED. THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENT WAS NOT RELINED OR EXTENDED WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENTS WAS SUCCESSFUL. THE STENT PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. RIGHT RENAL ARTERY: A COMPETITOR'S STENTS MEASURING 6 MM IN DIAMETER AND 22 MM IN LENGTH WAS PLACED. THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENT WAS NOT RELINED OR EXTENDED WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENT WAS SUCCESSFUL. THE STENT PATENCY MAINTAINED WITH NORMAL END ARTERY PERFUSION. LEFT RENAL ARTERY: A COMPETITOR'S STENTS MEASURING 7 MM IN DIAMETER AND 27 MM IN LENGTH WAS PLACED. THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENT WAS NOT RELINED OR EXTENDED WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENT WAS SUCCESSFUL. THE STENT PATENCY MAINTAINED WITH NORMAL END ARTERY PERFUSION. A FENESTRATED PROXIMAL CUSTOM-MADE DEVICE (CMD) FROM ANOTHER MANUFACTURER WAS PLACED. THE DEVICE WAS PLANNED FOR THIS PATIENT. NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE WERE EXPERIENCED. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. AN ABDOMINAL AORTIC ANEURYSM BIFURCATED CUSTOM-MADE DEVICE FROM ANOTHER MANUFACTURER WAS PLACED. NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE WERE EXPERIENCED. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. ILIAC ARTERY COMPONENT: A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-56-ZT) WAS PLACED ON THE PATIENT'S RIGHT. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. ILIAC ARTERY COMPONENT: A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-13-74-ZT) WAS PLACED ON THE PATIENT'S LEFT. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. PROCEDURAL IMAGING IN THE FORM OF AN ANGIOGRAM AND CONE BEAM COMPUTED CONTRAST WAS COMPLETED ON (B)(6) 2024. ALL STENT GRAFTS AND INTENDED SIDE BRANCH STENTS WERE PATENT AT THE CONCLUSION OF THE PROCEDURE, NO ENDOLEAKS WERE PRESENT. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. ALL TARGET SIDE BRANCH STENTS WERE INTACT. TOTAL CONTRAST VOLUME USED DURING THE PROCEDURE: 85 ML. CONTRAST DOSE: 1.1 ML/KG. FLUOROSCOPY TIME: 43 MINUTES. TOTAL GRAY USED: 412 MGY. TOTAL DOSE AREA PRODUCT: 49. TOTAL DOES AREA PRODUCT UNITS: CGY*CM2. FUSION WAS USED DURING THE PROCEDURE. THE ESTIMATED BLOOD LOSS DURING THE PROCEDURE WAS 50 ML. DURING THE PROCEDURE NO RED BLOOD CELLS/FRESH FROZEN PLASMA/CRYOPRECIPITATE/PLATELETS/CELLSAVER WERE GIVEN. CARDIAC OUTPUT REDUCTION WAS NOT USED. CARBON DIOXIDE FLUSHING WAS NOT USED. THE PROXIMAL SEAL ZONE WAS THE NATIVE AORTA. NO NEUROMONITORING WAS USED DURING THE PROCEDURE. PROCEDURAL TIME (24-HOUR CLOCK): TIME ARRIVES IN ROOM: 08:15. TIME OF FIRST INCISION OR ARTERIAL PUNCTURE: 09:18. TIME OF LAST ACCESS CLOSURE: 11:30. TIME LEAVES ROOM: 11:58. DURATION OF PROCEDURE (FROM FIRST INCISION TO LAST ACCESS CLOSURE): 132 MINUTES. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM AND DID NOT REQUIRE RE-INTUBATION. THE PATIENT DID NOT REQUIRE A TRACHEOSTOMY. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL PROBLEMS OR COMPLICATIONS DURING THE STUDY PROCEDURE. ON (B)(6) 2024 THE PATIENT HAD LIMB ISCHEMIA AND RIGHT MOTOR DEFICIT OF THE RIGHT LOWER LIMB. THE PATIENT REQUIRED A RIGHT FEMORAL ENDARTERECTOMY. THE SITE INDICATED THIS WAS RELATED TO THE PROCEDURE. THE RIGHT ILIAC OCCLUSION WAS REPORTED TO HAVE BEEN CAUSED BY THE ADVANCEMENT OF THE DELIVERY SYSTEM OF THE DEVICE. THE SITE ALSO INDICATED THAT THE EVENT WAS PROBABLY RELATED TO THE TREATED DISEASE DUE TO HEAVILY DISEASED AND CALCIFIED ILIOFEMORAL ACCESS AND ADVANCEMENT OF THE DELIVERY SYSTEM. THE RIGHT FEMORAL ENDARTERECTOMY WAS CONSIDERED SUCCESSFUL. THE PATIENT STAYED IN THE INTENSIVE CARE UNIT FOR SIX DAYS. THE PATIENT RECEIVED ONE UNIT OF PACKED RED BLOOD CELLS OVER ENTIRE HOSPITALIZATION INCLUDING THE OPERATION. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA), CLOPIDOGREL, AND LOW WEIGHT MOLECULAR HEPARIN (LOVENOX). THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024 AND WAS NOT PRESCRIBED SUPPLEMENTAL OXYGEN. THE SUBJECT OF THIS REPORT IS THE OCCLUSION OF THE RIGHT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-56-ZT) THAT OCCURRED ON (B)(6) 2024. POST PROCEDURE THE PATIENT EXPERIENCED RIGHT MOTOR DEFICIT OF THE RIGHT LOWER LIMB. IT WAS REPORTED THAT THE PATIENT HAD AN OCCLUSION. THE OCCLUSION REQUIRED A SECONDARY INTERVENTION WHERE A RIGHT FEMORAL ENDARTERECTOMY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1924381 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | G55237 | 15771932 | 10827002552378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Required Intervention | BEGRAFT PERIPHERAL 10MM X 27 MM-SMA| BEGRAFT PERIPHERAL 6 MM X 22 MM RIGHT RENAL ARTERY| BEGRAFT PERIPHERAL 7 MM X 27 MM LEFT RENAL ARTERY| COOK INC. RPN: ZSLE-13-74-ZT, LOT 15996340| COOK RPN: AAA-BIFURCATED-GRAFT, LOT AC1159589| COOK RPN:PRE-LOADED-FENESTRATED-PROX,LOT AC1159588| ICOVER 7 MM X 17 MM-CELIAC ARTERY |