BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 8869452 · Received August 7, 2019

    Report

    Report Number
    3007284313-2019-00243
    Event Type
    Injury
    Date Received
    August 7, 2019
    Date of Event
    July 24, 2019
    Report Date
    September 4, 2019
    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 · 1

    PMA (510K) #: K172567. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE® MOLDING AND OCCLUSION BALLOON CATHETER (MOB); ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO INCLUDE: EMBOLIZATION. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) IS BEING CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. ANGIOPLASTY WAS PERFORMED USING A GORE® MOLDING AND OCCLUSION BALLOON CATHETER (MOB). IT WAS REPORTED THAT PREOPERATIVELY THE PATIENT¿S LEFT RENAL ARTERY HAD STENOSIS PRESENT. HOWEVER, NO PROBLEM WITH BLOOD FLOW WAS OBSERVED. IT WAS ALSO REPORTED THAT MANY MURAL THROMBUS WAS NOTED WITHIN THE PATIENT¿S AORTA. POST DEPLOYMENT OF ALL ENDOPROSTHESES; A TYPE II ENDOLEAK ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY, AND DIMINISHED BLOOD FLOW TO THE LEFT RENAL ARTERY WAS REPORTED DUE TO A PLAQUE SHIFTING DURING THE PROCEDURE THE PHYSICIAN CHOSE TO MONITOR THE TYPE II ENDOLEAK AND IMPLANT A EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM IN THE LEFT RENAL ARTERY TO SECURE BLOOD FLOW TO THE LEFT RENAL. POST IMPLANT, IMPROVED BLOOD FLOW TO THE LEFT RENAL ARTERY WAS REPORTED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN DOES NOT KNOW IF PLACEMENT OF THE DEVICE; OR ANGIOPLASTY THAT WAS PERFORMED, CAUSED OR CONTRIBUTED TO THE SHIFT OF PLAQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664241 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES 20549525 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| O| R