BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 25330231 · Received May 29, 2026

    Report

    Report Number
    1820334-2026-00569
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    February 12, 2026
    Report Date
    May 29, 2026
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    00827002552395
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1 - TITLE: PRINCIPAL INVESTIGATOR. H3 - DEVICE EVALUATED BY MFG?: THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE 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. 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 DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TYPE 1B ENDOLEAK ORIGINATING FROM THE RIGHT MOST DISTAL ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS IDENTIFIED ON TWELVE MONTH FOLLOW UP COMPUTED TOMOGRAPHY (CT). PRE-PROCEDURAL COMPUTED TOMOGRAPHY (CT) WITH CONTRAST IMAGING WAS COMPLETED ON (B)(6) 2025, 62 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 THE ARTERIES MENTIONED WERE PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY (SMA), RIGHT RENAL ARTERY, LEFT RENAL ARTERY WERE ALL PATENT AND NO STENOSIS GREATER THAN 50% WAS PRESENT. THE BILATERAL COMMON ILIAC AND INTERNAL ILIAC ARTERIES WERE PATENT. THE AORTIC VALVE WAS MECHANICAL. THE AORTIC ARCH WAS NOT A BOVINE CONFIGURATION. THE MAXIMUM DIAMETER OF THE DISEASED AORTA ON CENTERLINE WAS 60 MM. THE INTENDED PROXIMAL SEAL WAS ZONE 5: MID DESCENDING AORTA TO CELIAC. THE LEFT AND RIGHT INTENDED DISTAL LANDING ZONE WAS ZONE 11: EXTERNAL ILIAC ARTERY. PRE-PROCEDURE CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2025, ONE DAY PRIOR TO THE PROCEDURE. THE PRIMARY INDICATION WAS AORTIC DEGENERATIVE ANEURYSM, THORACIC ABDOMINAL AORTIC ANEURYSM (TAAA) EXTENT IV (ABDOMINAL ANEURYSM EXTENDING UP TO THE CELIAC AXIS). THERE WAS NO HISTORY OF DEGENERATIVE ANEURYSM GROWTH OF MORE THAN OR EQUAL TO 1.0 CM PER YEAR. AFTER PRIOR REPAIR THE PATIENT HAD NOT REQUIRED A RESCUE REPAIR AFTER PRIOR REPAIR. THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. THE PATIENT WAS PRESCRIBED ASPIRIN (SALICYLIC ACID) AT THE TIME OF THE PROCEDURE. PERCUTANEOUS ACCESS WAS ACHIEVED IN THE RIGHT AND LEFT FEMORAL ARTERIES. CUT DOWN ACCESS WAS REQUIRED IN THE LEFT AXILLARY. AN ENDOVASCULAR ILIAC CONDUIT WAS NOT PERFORMED AT THE TIME OF THE PROCEDURE. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE PROCEDURE: CELIAC ARTERY: A COMPETITOR'S STENT MEASURING 8 MM IN DIAMETER AND 79 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. CELIAC ARTERY: A COMPETITOR'S STENT MEASURING 6 MM IN DIAMETER AND 50 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 8 MM IN DIAMETER AND 59 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 STENT MEASURING 6 MM IN DIAMETER AND 39 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. RIGHT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 6 MM IN DIAMETER AND 50 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 STENT MEASURING 6 MM IN DIAMETER AND 59 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 STENT MEASURING 6 MM IN DIAMETER AND 50 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) FROM WILLIAM COOK AUSTRALIA, ZENITH FENESTRATED GRAFT, RPN: THORACO-ABDOMINAL-SIDE-BRANCH-LP WAS PLACED. THE DEVICE WAS PLANNED FOR THE PATIENT. NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE CMD DEVICE WERE EXPERIENCED. THE DELIVERY AND DEPLOYMENT OF THE MAIN CMD DEVICE WAS CONSIDERED SUCCESSFUL. A CUSTOM-MADE DEVICE (CMD) FROM WILLIAM COOK AUSTRALIA, RPN: AAA-BIFURCATED-GRAFT WAS PLACED. THE DEVICE WAS PLANNED FOR THE PATIENT. NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE CMD DEVICE WERE EXPERIENCED. THE DELIVERY AND DEPLOYMENT OF THE MAIN CMD DEVICE WAS CONSIDERED SUCCESSFUL. RIGHT ILIAC ARTERY: COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN: ZSLE-16-90-ZT 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. LEFT ILIAC ARTERY: A COMPETITOR'S STENT MEASURING 10 MM IN DIAMETER AND 79 MM LENGTH WAS PLACED. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. LEFT ILIAC ARTERY: A COMPETITOR'S STENT MEASURING 13 MM IN DIAMETER AND 50 MM LENGTH WAS PLACED. 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 (ANGIOGRAM) WAS COMPLETED ON (B)(6) 2025. ALL STENT GRAFTS AND INTENDED SIDE BRANCH STENTS WERE PATENT AND INTACT AT THE CONCLUSION OF THE PROCEDURE. NO ENDOLOEAKS WERE PRESENT AT THE CONCLUSION OF THE CASE. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. ALL TARGET VESSELS WERE PATENT. ALL TARGET SIDE BRANCH STENTS WERE INTACT. TOTAL CONTRAST VOLUME USED DURING THE PROCEDURE: 150 ML. CONTRAST DOSE: 2 ML/KG. FLUOROSCOPY TIME: 32 MINUTES. TOTAL GRAY USED: 1371 MGY. TOTAL DOSE AREA PRODUCT: 122 CGY*CM2. FUSION WAS USED DURING THE PROCEDURE. THE PATIENT WAS NOT GIVEN ANY RED BLOOD CELLS, FRESH FROZEN PLASMA, CRYOPRECIPITATE, PLATELETS, OR CELL SAVER DURING THE PROCEDURE. NO NEUROMONITORING WAS USED DURING THE PROCEDURE. PROCEDURAL TIME (24-HOUR CLOCK): TIME ARRIVES IN ROOM: 19:59. TIME OF FIRST INCISION OR ARTERIAL PUNCTURE: 14:25. TIME OF LAST ACCESS CLOSURE: 16:51. TIME LEAVES ROOM: 17:08. DURATION OF PROCEDURE (FROM FIRST INCISION TO LAST ACCESS CLOSURE): 146 MINUTES. SIDE BRANCH CATHETERIZATION AND PLACEMENT OF ALL BRIDGING STENTS WERE SUCCESSFUL. NO ADDITIONAL PROCEDURES WERE PERFORMED DURING THE CMD PROCEDURE. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL PROBLEMS OR COMPLICATIONS DURING THE STUDY PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WHERE HE STAYED TWO NIGHTS. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM. THE PATIENT WAS NOT REINTUBATED AND DID NOT REQUIRE A TRACHEOSTOMY. THE PATIENT WAS NOT DISCHARGED ON SUPPLEMENTAL OXYGEN. AT DISCHARGE, THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA), CLOPIDOGREL, AND A STATIN. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. A ONE MONTH FOLLOW UP CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2025, FIVE DAYS POST PROCEDURE. THE RIGHT ANKLE BRACHIAL INDEX WAS NOT ASSESSED. THE LEFT ANKLE BRACHIAL INDEX WAS 0.64. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA), ANTIPLATELET, AND A STATIN AT DISCHARGE. SINCE THE LAST VISIT, THE PATIENT HAS NOT HAD ANY SIGNIFICANT MEDICAL PROBLEMS OR BEEN HOSPITALIZED FOR ANY REASON. CT IMAGING WAS COMPLETED. FOLLOW UP CT IMAGING WITH CONTRAST WAS COMPLETED ON (B)(6) 2025, THREE DAYS POST PROCEDURE. NO OCCLUSION OR STENOSIS GREATER THAN 50% WAS NOTED IN THE CELIAC, SMA, RIGHT RENAL, OR LEFT RENAL ARTERIES. ALL STENT GRAFTS WERE PATENT. A NEW TYPE 2 ENDOLEAK WAS PRESENT. NO SECONDARY INTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. THE MAXIMUM DIAMETER OF THE DISEASED AORTA FROM OUTER WALL TO OUTER WALL (OW TO OW) WAS 54 MM. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. ALL INTENDED SIDE BRANCH STENTS WERE INTACT. A SIX MONTH (46-182 DAYS) CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2026, 162 DAYS POST PROCEDURE. BILATERAL ANKLE BRACHIAL INDEX WAS NOT ASSESSED. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA) AND A STATIN MEDICATION. SINCE THE LAST VISIT, THE PATIENT HAS NOT HAD ANY SIGNIFICANT MEDICAL PROBLEMS OR BEEN HOSPITALIZED FOR ANY REASON. NO FOLLOW UP IMAGING WAS COMPLETED AS IT WAS NOT A STANDARD OF CARE. BLOOD TESTS WERE NOT COMPLETED. A TWELVE MONTH (183-547 DAYS) CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2026, 191 DAYS POST PROCEDURE. BILATERAL ANKLE BRACHIAL INDEX WAS NOT ASSESSED. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA) AND A STATIN MEDICATION. SINCE THE LAST VISIT, THE PATIENT HAS NOT HAD ANY SIGNIFICANT MEDICAL PROBLEMS OR BEEN HOSPITALIZED FOR ANY REASON. CT IMAGING WAS COMPLETED. CT IMAGING WITH CONTRAST COMPLETED ON (B)(6) 2026 WAS REVIEWED. NO OCCLUSION OR STENOSIS GREATER THAN 50% WAS NOTED IN THE CELIAC, SMA, RIGHT RENAL, OR LEFT RENAL ARTERIES. ALL STENT GRAFTS WERE PATENT. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. ALL INTENDED SIDE BRANCH STENTS WERE INTACT. A NEW TYPE 1B ENDOLEAK WAS PRESENT ON THE RIGHT MOST DISTAL ILIAC COMPONENT. NO SECONDARY INTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. THE MAXIMUM DIAMETER OF THE DISEASED AORTA FROM OUTER WALL TO OUTER WALL (OW TO OW) WAS 61 MM. THIS COMPLAINT CAPTURES THE TYPE 1B ENDOLEAK FROM THE MOST DISTAL RIGHT ILIAC LIMB (ZSLE-16-90-ZT), IN WHICH NO SECONDARY INTERVENTION HAS TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94735 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC G55239 16585210 00827002552395

    Patients

    Seq Age Sex Outcome Treatment
    1