BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT

    MDR report key: 22192666 · Received June 12, 2025

    Report

    Report Number
    3002808486-2025-00131
    Event Type
    Death
    Date Received
    June 12, 2025
    Date of Event
    November 20, 2020
    Report Date
    July 3, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF#: (B)(4). BASED ON RESPONSE RECEIVED TO REQUESTED INFORMATION FROM THE SITE IT IS CONCLUDED THAT THERE ARE NO INDICATIONS THAT THE ZTA DEVICES ARE IMPLICATED IN THE EVENT OR THAT THE PROCEDURE IS RELATED TO THE DEATH AND THEREBY THE EVENT IS NO LONGER CONSIDERED REPORTABLE. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D4) CATALOG #: ZTA-PT-42-38-225 AND ZTA-PT-38-34-217. D4) LOT #: E3943633 AND E3953730. 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.

    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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO STUDY (B)(6): ZENITH ALPHA THORACIC POST MARKET RETROSPECTIVE STUDY): SYNOPSIS: THE PATIENT EXPERIENCED HEMORRHAGE/HEMORRHAGIC SHOCK 18 DAYS POST-PROCEDURE AND DIED 27 DAYS POST-PROCEDURE. ON (B)(6) 2020, THIS 79-YEAR-OLD MALE PATIENT WAS ROUTINELY TREATED FOR CHRONIC THORACIC AORTIC DISSECTION TYPE B WITH PLACEMENT OF A PROXIMAL ZTA-PT-42-38-225 AND A DISTAL ZTA-PT-38-34-217, STARTING AT ZONE 2. ON (B)(6) 2020, THE PATIENT EXPERIENCED HEMORRHAGE/HEMORRHAGIC SHOCK. THE EVENT WAS TREATED WITH ANTIBIOTICS, INOTROPIC CARDIAC SUPPORT, AND OXYGEN. THE EVENT LED TO DEATH. THE SITE NOTED THE RELATIONSHIP OF THE EVENT TO THE STUDY DEVICE, PROCEDURE, AND TREATED AORTIC DISEASE AS ¿RETROSPECTIVE EVENT, UNABLE TO DETERMINE. PATIENT OUTCOME: ON (B)(6) 2020, THE PATIENT DIED. THE CAUSE OF DEATH WAS HEMORRHAGIC SHOCK. DESCRIPTION OF CIRCUMSTANCES INCLUDES ¿PCR COVID 19 POSITIVE.¿ RELATIONSHIP ASSESSMENT OF DEATH TO STUDY DEVICE AND PROCEDURE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669400 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death