BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

    MDR report key: 13266394 · Received January 17, 2022

    Report

    Report Number
    1820334-2022-00066
    Event Type
    Malfunction
    Date Received
    January 17, 2022
    Report Date
    February 8, 2022
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    CORRECTION: IN ADDITIONAL INFORMATION IT WAS CONFIRMED THAT THE COMPLAINT DEVICE IS NOT MANUFACTURED BY COOK INC. AS SUCH, THERE IS NO ALLEGED DEFICIENCY IN IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF A COOK INC MANUFACTURED DEVICE. THEREFORE, THIS EVENT NO LONGER MEETS THE SET CRITERIA FOR A REPORTABLE EVENT PER 21 CFR PART 820. ADDITIONALLY, THIS EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS THIS DEVICE IS NOT SOLD IN THE US AND THERE IS NOT A SAME/SIMILAR DEVICE MANUFACTURED BY COOK INC THAT IS MARKETED IN THE U.S. NO FURTHER REPORTS REGARDING THIS EVENT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNKNOWN 20MM DIAMETER AORTIC LIMB GRAFT OCCLUDED FOLLOWING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE CASE OCCURRED ON (B)(6) 2021. AT THE COMPLETION OF THE CASE, THE SURGEON NOTED THAT THE ANGIOGRAM, "LOOKED GREAT." ONE LIMB WAS LATER FOUND TO BE OCCLUDED. IT WAS NOTED THAT THE PATIENT HAD, "A LOT OF THROMBUS IN THE NECK AND IT LOOKS LIKE ITS COME FROM ABOVE." ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 0

    IN ADDITIONAL INFORMATION RECEIVED ON 31JAN2022 THE DEVICE RPN WAS PROVIDED AND IT WAS CONFIRMED THAT THE COMPLAINT DEVICE IS NOT MANUFACTURED BY COOK INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625884 MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown