BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 8772112 · Received July 9, 2019

    Report

    Report Number
    3007284313-2019-00196
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    June 19, 2019
    Report Date
    August 19, 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

    H10/11: ADDITIONAL MANUFACTURER NARRATIVE/CORRECTED DATA - THIS SUPPLEMENTAL IS BEING SENT TO INCLUDE THE 501(K) NUMBER FOR THE PRODUCT. G5: 510(K) NUMBER: K172567.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE GORE® MOLDING AND OCCLUSION BALLOON INSTRUCTIONS FOR USE, ADVERSE EVENTS WHICH MAY REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO TRAUMA TO THE VESSEL WALL, INCLUDING SPASM, DISSECTION, PERFORATION OR RUPTURE.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM RUPTURE WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. AFTER ALL DEVICES WERE DEPLOYED, AN IMAGING IDENTIFIED A PROXIMAL TYPE I ENDOLEAK. THE AORTIC EXTENDER COMPONENT, WHICH WAS IMPLANTED MOST PROXIMALLY, WAS PERFORMED BALLOONING USING GORE® MOLDING & OCCLUSION BALLOON SEVERAL TIMES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, COMPUTED TOMOGRAPHY IMAGING SHOWED A TYPE B DISSECTION OF THE DESCENDING AORTA. THE PHYSICIAN SUGGESTED THAT THE DISSECTION WAS CAUSED BY THE BALLOONING OF THE AORTIC EXTENDER COMPONENT, OR GUIDE WIRE OPERATION IN THE LEFT SUBCLAVIAN ARTERY. IT WAS REPORTED THAT THE COMPLETION IMAGING WHICH TOOK PLACE ON THE DATE OF THE IMPLANT PROCEDURE ON (B)(6) DID NOT SHOW THE DISSECTION. NO TREATMENT WAS PERFORMED FOR THE DISSECTION. THE PHYSICIAN DECIDED TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566753 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES 19998632 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other PLA320400J/18798126| PLA320400J/18798126