BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 24412175 · Received February 23, 2026

    Report

    Report Number
    3002808486-2026-00033
    Event Type
    Death
    Date Received
    February 23, 2026
    Date of Event
    February 2, 2026
    Report Date
    April 20, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    00827002449718
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). B2) DATE OF DEATH: DUE TO A SYSTEMIC ERROR, THE DATE OF DEATH WAS ENTERED INCORRECTLY. THE CORRECT DATE OF DEATH IS UNKNOWN. G4) SIMILAR TO DEVICE MARKETED UNDER 510(K)/PMA: P140016. INVESTIGATION IS STILL IN PROGRESS 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 COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IN 2022, EMERGENCY TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) WAS PERFORMED FOR IMPENDING RUPTURE OF A THORACIC AORTIC ANEURYSM. USING A 2-DEBRANCH TECHNIQUE, ZTA-P-42-225-W1 (PROXIMAL) AND ZTA-DE-34-112-W1 (DISTAL) WERE PLACED FROM ZONE 1. DATE UNKNOWN, FINDINGS SUGGESTIVE OF A PROXIMAL TYPE I ENDOLEAK DUE TO PROXIMAL ANEURYSM EXPANSION WERE OBSERVED ON THE PROXIMAL SIDE OF THE ZTA-P-42-225-W1 PLACED IN ZONE 1. COIL EMBOLIZATION WAS PERFORMED FOR THE ENDOLEAK. ON (B)(6) 2026, ADDITIONAL PROCEDURE WAS PERFORMED FOR A DISTAL TYPE I ENDOLEAK DUE TO ANEURYSM EXPANSION AT THE DISTAL END OF THE PREVIOUSLY PLACED ZTA-DE-34-112-W1 (HANDLED IN RELATED COMPLAINT). ZTA-P-28-109-W1 AND ZTA-P-36-209-W1 WERE PLACED OVERLAPPING THE EXISTING STENT GRAFT, STARTING JUST ABOVE THE CELIAC ARTERY. THE PROCEDURE WAS COMPLETED WITHOUT ENDOLEAK. PROXIMAL TYPE I ENDOLEAK DUE TO PROXIMAL ANEURYSM EXPANSION HAS BEEN ALSO IDENTIFIED. HOWEVER, IT WAS DETERMINED TO BE CONTROLLED BY THE PREVIOUS COIL EMBOLIZATION, AND TREATMENT DURING THIS TEVAR WAS NOT PLANNED. ADDITIONALLY, DURING THE ANGIOGRAPHY PERFORMED FROM THE PROXIMAL SIDE DURING THIS TEVAR, THE PHYSICIAN JUDGED THAT THE FILLING OBSERVED WITHIN THE ANEURYSM COULD POTENTIALLY BE DUE TO TYPE II ENDOLEAK RATHER THAN PROXIMAL TYPE I ENDOLEAK, SO IT WAS DECIDED TO MONITOR THE SITUATION AND DETERMINE THE TREATMENT PLAN FOR THE PROXIMAL NECK EXPANSION LATER. ON 06FEB2026, THE REP RECEIVED A NOTIFICATION OF THE PATIENT'S DEATH FROM THE DISTRIBUTOR. HE WAS TOLD THAT THE PATIENT'S CONDITION DETERIORATED RAPIDLY AFTER RETURNING TO THE WARD AND DIED SEVERAL HOURS AFTER THE TEVAR ENDED DUE TO RUPTURE OF THE PROXIMAL NECK ANEURYSM (HANDLED IN THIS COMPLAINT). THE COMPLAINT REPORTED BY THE USER WAS CONFIRMED. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR SALES REPRESENTATIVE TESTIMONY. THE DEVICE EVALUATION COULD NOT BE PERFORMED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. EVENT IS RELATED TO THE IMPLANTED STENT GRAFT. CLINICAL ASSESSMENT WAS RECEIVED. A CLINICAL ASSESSMENT WAS PERFORMED BY COOK MEDICAL ADVISER AND CONFIRMED: THIS PATIENT DIED AFTER A SECOND TEVAR PROCEDURE FOR A DISTAL TYPE 1B ENDOLEAK WITH ANEURYSM EXPANSION. HOWEVER, THE CAUSE OF DEATH WAS AN ANEURYSM RUPTURE DUE TO A PERSISTENT TYPE1A ENDOLEAK RELATED TO THE FIRST TEVAR PROCEDURE FOUR YEARS EARLIER. A REVIEW OF THE MANUFACTURING RECORDS AND/OR SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES/NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INVESTIGATION CONCLUDES THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. THERE IS EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU)/AND OR LABEL. THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE PRODUCT LABELING AND/OR INSTRUCTIONS, THEREFORE IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION. A DEFINITIVE CAUSE WAS IDENTIFIED; ACCORDING TO THE CLINICAL ASSESSMENT THE CAUSE OF DEATH WAS AN ANEURYSM RUPTURE DUE TO A PERSISTENT TYPE1A ENDOLEAK RELATED TO THE FIRST TEVAR PROCEDURE FOUR YEARS EARLIER. FURTHERMORE, ZTA PLACED IN THE AORTIC ARCH WHICH IS OUT OF INTENDED USE ACCORDING TO THE IFU. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. TRENDING WILL MONITOR IF ANY FUTURE ACTIONS ARE REQUIRED. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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 COOK 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IN 2022: EMERGENCY THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WAS PERFORMED FOR IMPENDING RUPTURE OF A THORACIC AORTIC ANEURYSM. USING A 2-DEBRANCH TECHNIQUE, ZTA-P-42-225-W1 (PROXIMAL SIDE, THIS COMPLAINT) AND ZTA-DE-34-112-W1 (DISTAL SIDE, (B)(4)) WERE PLACED FROM ZONE 1. DATE UNKNOWN: FINDINGS SUGGESTIVE OF A PROXIMAL TYPE I ENDOLEAK DUE TO PROXIMAL ANEURYSM EXPANSION WERE OBSERVED ON THE PROXIMAL SIDE OF THE ZTA-P-42-225-W1 PLACED IN ZONE 1. COIL EMBOLIZATION WAS PERFORMED FOR THE ENDOLEAK. 02FEB2026: ADDITIONAL PROCEDURE WAS PERFORMED FOR A DISTAL TYPE I ENDOLEAK DUE TO ANEURYSM EXPANSION AT THE DISTAL END OF THE PREVIOUSLY PLACED ZTA-DE-34-112-W1. ZTA-P-28-109-W1 AND ZTA-P-36-209-W1 WERE PLACED OVERLAPPING THE EXISTING STENT GRAFT, STARTING JUST ABOVE THE CELIAC ARTERY. THE PROCEDURE WAS COMPLETED WITHOUT ENDOLEAK. PROXIMAL TYPE I ENDOLEAK DUE TO PROXIMAL ANEURYSM EXPANSION HAS BEEN ALSO IDENTIFIED. HOWEVER, IT WAS DETERMINED TO BE CONTROLLED BY THE PREVIOUS COIL EMBOLIZATION, AND TREATMENT DURING THIS TEVAR WAS NOT PLANNED. ADDITIONALLY, DURING THE ANGIOGRAPHY PERFORMED FROM THE PROXIMAL SIDE DURING THIS TEVAR, THE PHYSICIAN JUDGED THAT THE FILLING OBSERVED WITHIN THE ANEURYSM COULD POTENTIALLY BE DUE TO TYPE II ENDOLEAK RATHER THAN PROXIMAL TYPE I ENDOLEAK, SO IT WAS DECIDED TO MONITOR THE SITUATION AND DETERMINE THE TREATMENT PLAN FOR THE PROXIMAL NECK EXPANSION LATER. ON (B)(6) 2026: THE REP RECEIVED A NOTIFICATION OF THE PATIENT'S DEATH FROM THE DISTRIBUTOR. HE WAS TOLD THAT THE PATIENT'S CONDITION DETERIORATED RAPIDLY AFTER RETURNING TO THE WARD AND DIED SEVERAL HOURS AFTER THE TEVAR ENDED DUE TO RUPTURE OF THE PROXIMAL NECK ANEURYSM. PATIENT OUTCOME: THE PATIENT SUDDENLY DETERIORATED AFTER RETURNING TO THE WARD AND DIED FROM THE RUPTURE OF ANEURYSM IN THE PROXIMAL SIDE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464173 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G44971 E4278116 00827002449718

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Death