BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 9665412 · Received February 4, 2020

    Report

    Report Number
    3007284313-2020-00029
    Event Type
    Injury
    Date Received
    February 4, 2020
    Date of Event
    January 27, 2020
    Report Date
    March 9, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    UDI-DI
    00733132639489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE 213- A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    G1, G5, H6: ADDITIONAL/CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K172567. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. POST DEPLOYMENT OF ALL DEVICES, DURING TOUCH UP ANGIOPLASTY THE CONTRALATERAL LEG COMPONENT POSITIONED IN THE RIGHT COMMON ILIAC ARTERY (RCIA) WAS UNINTENTIONALLY MOVED PROXIMALLY, LEAVING A DISTAL TYPE I ENDOLEAK. AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO EXTEND COVERAGE AND TREAT THE ENDOLEAK AND RESULTED IN UNINTENTIONAL COVERAGE OF THE RIGHT INTERNAL ILAC ARTERY (RIIA). IT WAS REPORTED THAT THE PHYSICIAN MISINTERPRETED THE POSITION OF THE RADIOPAQUE MARKER. ANGIOGRAPHY CONFIRMED THE DISTAL TYPE I ENDOLEAK ON THE RIGHT SIDE WAS RESOLVED, HOWEVER A DISTAL TYPE I ENDOLEAK IN THE LEFT LEG WAS NOW OBSERVED. TOUCH-UP BALLOONING WAS PERFORMED AGAIN, AND THE DISTAL TYPE I ENDOLEAK IN THE LEFT LEG WAS RESOLVED. TO ALLEVIATE THE POSSIBILITY OF POSTOPERATIVE OCCLUSION OF THE RIIA, A BARE METAL STENT WAS IMPLANTED DISTAL TO THE RIGHT LEG. POST OPERATIVE BALLOONING WAS PERFORMED WITH A PTA BALLOON. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128382 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES MOB37 21297915 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O| R