BEUDAMED
    FDA Adverse Event Death Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 9616018 · Received January 22, 2020

    Report

    Report Number
    3007284313-2020-00014
    Event Type
    Death
    Date Received
    January 22, 2020
    Date of Event
    January 21, 2020
    Report Date
    February 4, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    UDI-DI
    00733132639489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5,B6: ADDITIONAL/CORRECTED INFORMATION. G9: PLEASE NOTE THAT THIS EVENT WAS REPORTED IN MEDWATCH #3013164176-2020-00007. DETAILS OF THE EVENT REQUIRED A SEPARATE MEDWATCH SUBMISSION FOR THE GORE® MOLDING & OCCLUSION BALLOON CATHETER; AS SUCH THIS MEDWATCH IS BEING SUBMITTED. H6: CODE 213- A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ENLARGING 5.5CM ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT POST DEPLOYMENT OF THE DEVICES A PROXIMAL TYPE I ENDOLEAK WAS SEEN AND A GORE® AORTIC EXTENDER COMPONENT WAS PLACED PROXIMALLY. DURING ANGIOPLASTY OF THE AORTIC EXTENDER COMPONENT USING A GORE® MOLDING & OCCLUSION BALLOON (MOB), INCREASED EXTRAVASATION WAS SEEN AND ANGIOGRAPHY DETERMINED A RUPTURE AT THE ORIGIN OF THE LEFT RENAL ARTERY DUE TO SUSPECTED OVER INFLATION OF THE BALLOON. REPORTEDLY DUE TO THE PATIENT'S SHORT ANGULATED NECK COUPLED WITH CALCIFICATION IN THE AORTIC NECK; GOOD SEAL WAS UNABLE TO BE ACHIEVED. THE PHYSICIAN CONVERTED TO OPEN REPAIR WHEREIN GRAFTS WERE SEWN IN TO RELINE THE DEVICES. MASSIVE TRANSFUSION PROTOCOL WAS INITIATED FOR THE PATIENT WHO WAS TRANSFUSED WITH 11 LITRES. THE PROCEDURE WAS CONCLUDED WITH AN "OPEN" CLOSE FOR THE PATIENT, WITH A PLAN WAS TO REINTERVENE THE NEXT DAY AND PERFORM AN AX FEMORAL BYPASS. ON (B)(6) 2020, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: AS GORE WAS UNABLE TO DETERMINE WHICH DEVICE WAS INVOLVED IN THE EVENT IF ANY; ADDITIONAL DEVICE(S) ASSOCIATED INCLUDE: MOB37/20317994, UDI: (B)(4), MOB37/20317983, UDI: (B)(4). PATIENT MEDICATIONS INCLUDE BUT ARE NOT LIMITED TO: NORVASC, COZAAR, ATIVAN, LIPITOR, PRILOSEC, K-DUR, KLOR-CON, VITAMIN D, TYLENOL. PMA/510(K) #: K172567. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ENLARGING 5.5CM ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT POST DEPLOYMENT OF THE DEVICES WHEN PERFORMING COMPLETION ANGIOGRAPHY USING A GORE® MOLDING & OCCLUSION BALLOON (MOB) THE AORTA WAS RUPTURED AT THE ORIGIN OF THE LEFT RENAL ARTERY CAUSED BY SUSPECTED OVER INFLATION OF THE BALLOON. THE PATIENT WAS CONVERTED TO OPEN REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80939 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES MOB37 21167099 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| O| R SEE H10/11.