ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2026-00181
- Event Type
- Injury
- Date Received
- February 18, 2026
- Date of Event
- November 17, 2025
- Report Date
- May 18, 2026
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 00827002552418
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E3: PHYSICIAN, PROFESSOR OF VASCULAR SURGERY, PRINCIPAL INVESTIGATOR FOR (B)(4). H3 - DEVICE EVALUATED BY MFG? DEVICE NOT RETURNED TO MANUFACTURER. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: B5. CORRECTION: B5. 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.
IT WAS REPORTED THAT A KINK IN A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT) OCCURRED. A PRE-PROCEDURE CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2025, ONE DAY PRIOR TO THE PROCEDURE. THE PATIENT HAD AN AORTIC DEGENERATIVE ANEURYSM, JUXTARENAL (NECK WAS LESS THAN 10 MM) ABDOMINAL AORTIC ANEURYSM (AAA). THERE WAS NO HISTORY OF ANEURYSM GROWTH OF > OR EQUAL TO 1.0 CM PER YEAR. THE PATIENT HAD NOT UNDERGONE A PRIOR ENDOVASCULAR AORTIC REPAIR. PRE-PROCEDURAL COMPUTED TOMOGRAPHY (CT) WITH CONTRAST IMAGING WAS COMPLETED ON (B)(6) 2025, 98 DAYS PRIOR TO THE PROCEDURE. THE INNOMINATE ARTERY, RIGHT COMMON CAROTID ARTERY, RIGHT SUBCLAVIAN ARTERY, LEFT COMMON CAROTID ARTERY, LEFT SUBCLAVIAN ARTERY, AND CELIAC ARTERY WERE INCORPORATED INTO THE REPAIR. ALL ARTERIES MENTIONED WERE PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE SUPERIOR MESENTERIC ARTERY (SMA) WAS INCORPORATED IN THE REPAIR. THE ARTERY WAS PATENT. THE ARTERY WAS NOT STENOSED MORE THAN 50%. THE RIGHT RENAL ARTERY WAS INCORPORATED IN THE REPAIR. THE ARTERY WAS PATENT. THE ARTERY WAS NOT STENOSED MORE THAN 50%. THE LEFT RENAL ARTERY WAS NOT INCORPORATED INTO THE REPAIR. THE RIGHT COMMON ILIAC ARTERY WAS PATENT. THE LEFT COMMON ILIAC ARTERY WAS PATENT. THE RIGHT AND LEFT INTERNAL ILIAC ARTERIES WERE PATENT. THE AORTIC VALVE WAS NATIVE. THERE WAS NO AORTIC ARCH BOVINE CONFIGURATION. THE MAXIMUM DIAMETER OF THE DISEASED AORTA ON CENTERLINE WAS 77 MM. THE INTENDED PROXIMAL SEAL WAS ZONE 5: MID DESCENDING AORTA TO CELIAC THE LEFT INTENDED DISTAL LANDING ZONE WAS ZONE 10: COMMON ILIAC ARTERY. THE PATIENT UNDERWENT A BRANCHED ENDOVASCULAR AORTIC REPAIR (BEVAR) PROCEDURE ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. NO ANTIPLATELET THERAPY WAS PRESCRIBED AT THE TIME OF THE PROCEDURE. PERCUTANEOUS ACCESS WAS ACHIEVED IN THE LEFT AND RIGHT FEMORAL ARTERIES. AN ENDOVASCULAR ILIAC CONDUIT WAS NOT PERFORMED AT THE TIME OF THE PROCEDURE. TOTAL CONTRAST VOLUME USED DURING THE PROCEDURE: 210 ML. CONTRAST DOSE: 2.3 ML/KG. FLUOROSCOPY TIME: 60 MINUTES. TOTAL GRAY USED: 3607 MGY. TOTAL DOSE AREA PRODUCT: 504 CGY*CM2. FUSION WAS USED DURING THE PROCEDURE. THE ESTIMATED BLOOD LOSS DURING THE PROCEDURE WAS 175 ML. 175 ML OF CELLSAVER WAS GIVEN DURING THE PROCEDURE. CARDIAC OUTPUT REDUCTION WAS NOT USED. CARBON DIOXIDE FLUSHING WAS 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: 14:19. TIME OF FIRST INCISION OR ARTERIAL PUNCTURE: 14:30. TIME OF LAST ACCESS CLOSURE: 19:47. TIME LEAVES ROOM: 20:30. DURATION OF PROCEDURE (FROM FIRST INCISION TO LAST ACCESS CLOSURE): 317 MINUTES. DURING THE PROCEDURE, THE PATIENT HAD THE FOLLOWING DEVICES PLACED: CELIAC ARTERY: A COMPETITOR'S STENT MEASURING 10 MM IN DIAMETER AND 59 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 59 MM LENGTH WAS PLACED AS WELL AS ANOTHER COMPETITOR'S STENT MEASURING 11 MM IN DIAMETER AND 50 MM IN LENGTH. THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENTS WERE NOT RELINED OR EXTENDED WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENTS WAS SUCCESSFUL. THE STENTS PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. RIGHT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 8 MM IN DIAMETER AND 79 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 CUSTOM-MADE DEVICE (CMD), WILLIAM COOK AUSTRALIA (RPN: THORACO-ABDOMINAL-SIDE-BRANCH-LP) WAS PLACED. NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE THORACIC PROXIMAL EXTENSION CMD DEVICE WERE EXPERIENCED. THE DELIVERY AND DEPLOYMENT OF THE THORACIC PROXIMAL EXTENSION CMD DEVICE WAS CONSIDERED SUCCESSFUL. A DISTAL AORTIC CMD DEVICE, WILLIAM COOK AUSTRALIA (RPN: UNIBODY-24-115) WAS PLACED. THE DEVICE WAS PLANNED FOR THIS PATIENT. NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE CMD DEVICE WERE EXPERIENCED. THE DELIVERY AND DEPLOYMENT OF THE CMD DEVICE WAS CONSIDERED SUCCESSFUL. COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN: ZSLE-20-56-ZT) WAS PLACED ON THE LEFT. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN: ZSLE-20-56-ZT, LOT 16703089) WAS PLACED ON THE RIGHT. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. A COMPETITOR¿S STENT MEASURING 10 MM IN DIAMETER AND 57 MM IN LENGTH WAS PLACED ON THE LEFT ILIAC ARTERY. THE ARTERY WAS ABLE TO BE REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENT WAS RELINED 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. A COMPETITOR¿S STENT MEASURING 10 MM IN DIAMETER AND 57 MM IN LENGTH WAS PLACED ON THE RIGHT ILIAC ARTERY. THE ARTERY WAS ABLE TO BE REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENT WAS RELINED 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. SIDE BRANCH CATHETERIZATION AND PLACEMENT OF ALL BRIDGING STENTS WAS SUCCESSFUL. PROCEDURAL IMAGING IN THE FORM OF AN ANGIOGRAM WAS COMPLETED ON (B)(6) 2025. 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. A SPINAL DRAIN WAS NOT PLACED DURING THE PROCEDURE. DURING THE PROCEDURE, THERE WAS A FAILURE OF THE WOUND HEALING SYSTEM. SURGICAL INTERVENTION WAS REQUIRED. A THROMBOENDARTERECTOMY WAS COMPLETED. A COMPETITOR¿S ADHESIVE BANDAGE WAS APPLIED TO THE SUPERFICIAL CIRCUMFLEX ARTERY AND THE FEMORAL ARTERY SUPERFICIALLY ON THE RIGHT SIDE. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM AND DID NOT REQUIRE REINTUBATION OR A TRACHEOSTOMY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WHERE HE STAYED TWO NIGHTS. TWO DAYS POST PROCEDURE ON (B)(6) 2025, THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AND ANTIBIOTICS WERE ADMINISTERED. SIX DAYS POST PROCEDURE ON (B)(6) 2025 KINKING OF THE LEFT ILIAC GRAFT WAS IDENTIFIED. A ONE-MONTH CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2025, SEVEN DAYS POST PROCEDURE. THE LEFT AND RIGHT BRACHIAL INDEX WAS NOT ASSESSED. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA), ANTICOAGULANT, AND A STATIN. SINCE THE LAST VISIT, THE PATIENT HAS NOT HAD ANY SIGNIFICANT MEDICAL PROBLEMS OR BEEN HOSPITALIZED FOR ANY REASON. FOLLOW UP IMAGING IN THE FORM OF A CT WAS COMPLETED. A REVIEW OF THE FOLLOW UP CT IMAGING WITH CONTRAST THAT WAS COMPLETED ON (B)(6) 2025, SIX DAYS POST PROCEDURE WAS COMPLETED. ALL STENT GRAFTS WERE PATENT. NO ENDOLEAKS WERE PRESENT. NO OCCLUSION OR STENOSIS GREATER THAN 50% WAS PRESENT IN THE CELIAC ARTERY, SMA, OR RIGHT RENAL ARTERY. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES AND ALL INTENDED SIDE BRANCH STENTS WERE INTACT. THE PATIENT UNDERWENT A SECONDARY INTERVENTION ON (B)(6) 2025, 37 DAYS POST PROCEDURE. THE SECONDARY INTERVENTION WAS COMPLETED DUE TO IMAGING THAT OCCURRED AT THE 30-DAY VISIT THAT IDENTIFIED A KINK IN THE LEFT ILIAC. PERCUTANEOUS STENTING OF THE ¿NEOBIFURCATION¿ WITH TWO COMPETITOR¿S10 X 57 STENTS IN THE KISSING TECHNIQUE WAS COMPLETED. THE EVENT RESULTED IN IN-PATIENT HOSPITALIZATION. THE SECONDARY INTERVENTION WAS CONSIDERED SUCCESSFUL. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. THE PATIENT WAS NOT DISCHARGED ON SUPPLEMENTAL OXYGEN. AT DISCHARGE, THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA), CLOPIDOGREL, AND A STATIN. THE SUBJECT OF THIS REPORT IS THE KINK ON THE LEFT ILIAC LEG GRAFT ON THE LEFT (ZSLE-20-56-ZT) IDENTIFIED IN IMAGING ON (B)(6) 2025 WHICH REQUIRED A REINTERVENTION PROCEDURE ON (B)(6) 2025 WHERE TWO COMPETITORS 10 X 57 STENTS IN THE KISSING TECHNIQUE WAS COMPLETED.
ADDITIONAL INFORMATION WAS PROVIDED ON 18FEB2026. THE COMPETITOR'S 10 X 57 STENTS WERE NOT PLACED IN THE INDEX PROCEDURE. THE RIGHT SIDE KINK WAS TREATED BY STENTING OF THE NEO BIFURCATION WITH TWO 10 X 57 STENTS IN KISSING TECHNIQUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 365517 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | G55241 | 16698820 | 00827002552418 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |