BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 8761160 · Received July 3, 2019

    Report

    Report Number
    3007284313-2019-00190
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    June 6, 2019
    Report Date
    September 10, 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

    CORRECTED B3: DATE OF EVENT (B)(6) 2019.

    Additional Manufacturer Narrative · 0

    G5: PMA/510(K) #: K172567.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH AND GORE® MOLDING & OCCLUSION BALLOON. THE SHEATH WAS INSERTED FROM THE LEFT FEMORAL ARTERY. THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS WAS DEPLOYED AND THE PROXIMAL END WAS BALLOONED. TWO CONTRALATERAL LEG ENDPROSTHESES AND AN ILIAC EXTENDER ENDOPROSTHESIS WERE IMPLANTED IN THE RIGHT LIMB AND BALLOONING WAS PERFORMED. IMAGING WAS THEN TAKEN AND IT REVEALED A DISSECTION OF THE LEFT EXTERNAL ILIAC ARTERY. A CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED AND RELINED WITH A STENT (EPIC) IN THE LEFT EXTERNAL ILIAC ARTERY TO REPAIR THE DISSECTION. THE DISSECTION WAS REPORTEDLY RESOLVED. FINAL IMAGING IDENTIFIED A SUSPECTED PROXIMAL TYPE I OR TYPE II ENDOLEAK. BALLOONING WAS THEN PERFORMED AGAIN TO THE PROXIMAL END OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS. AFTER BALLOONING AN ENDOLEAK WAS STILL REPORTED. THE PHYSICIAN DECIDED TO MONITOR THE PATIENT AND IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY THE VESSEL DIAMETERS IN THE LEFT EXTERNAL ILIAC ARTERY WERE 8 MM AND NO RESISTANCE WAS FELT. THE PHYSICIAN STATED, ¿THAT IT COULD NOT BE DETERMINED WHEN THE DISSECTION OCCURRED AND WHICH PROCEDURE TRULY LED TO THE DISSECTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552685 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES 20051675 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R