BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT

    MDR report key: 15543361 · Received October 5, 2022

    Report

    Report Number
    1820334-2022-01587
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Report Date
    October 26, 2022
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BRAND NAME: DEVICE IS SUSPECTED TO BE A COOK MANUFACTURED DEVICE MAIN BODY GRAFT. INITIAL REPORTER NAME AND ADDRESS: POSTAL CODE: (B)(6). INITIAL REPORTER OCCUPATION: VASCULAR SURGEON. 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 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

    CORRECTION: FOLLOWING EXPERT IMAGE REVIEW OF THE COMPLAINT DEVICE, IT WAS CONFIRMED ON 25OCT2022 THAT THE IDENTITY OF THE GRAFT WAS A ZIMB-32-108. AS THIS DEVICE IS NOT MANUFACTURED BY COOK INC, NO ADDITIONAL SUPPLEMENTAL REPORTS REGARDING THIS EVENT WILL BE SUBMITTED BY COOK INC. ADDITIONALLY, THIS DEVICE IS NOT MARKETED IN THE US AND THERE IS NOT A SIMILAR DEVICE MANUFACTURED BY COOK INC THAT IS MARKETED IN THE US. 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

    COOK RECEIVED NOTIFICATION THAT A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN IDENTIFIED A TYPE 1A ENDOLEAK ON AN UNKNOWN COOK ENDOVASCULAR AORTIC REPAIR (EVAR) GRAFT. THE PHYSICIAN IS CURRENTLY UNDECIDED IF A REINTERVENTION PROCEDURE WILL BE COMPLETED UNTIL THE PATIENT HAS BEEN SEEN, IN ORDER TO DETERMINE IF THE PATIENT IS WELL ENOUGH TO EITHER EXPLANT THE GRAFT OR COMPLETE A FENESTRATED CUFF REPAIR. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING IDENTIFICATION OF THE GRAFT, DATE OF IMPLANT, REINTERVENTION DATE AND DETAILS, AND PATIENT OUTCOME HAVE BEEN REQUESTED BUT ARE UNKNOWN AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2467122 ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male