BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOB)

    MDR report key: 8493973 · Received April 8, 2019

    Report

    Report Number
    3007284313-2019-00102
    Event Type
    Injury
    Date Received
    April 8, 2019
    Date of Event
    March 12, 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

    G5: CORRECTED/ADDITIONAL INFORMATION TO INCLUDE THE 510(K) NUMBER: K172567.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE GORE® MOLDING & OCCLUSION BALLOON CATHETER INSTRUCTIONS FOR USE (IFU), DO NOT INFLATE THE BALLOON IN AREAS OF SIGNIFICANT CALCIFIED PLAQUE. BALLOON RUPTURE AND / OR VESSEL DAMAGE MAY OCCUR. ADDITIONALLY, PER IFU, ADVERSE EVENTS WHICH MAY REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO TRAUMA TO THE VESSEL WALL, INCLUDING SPASM, DISSECTION, PERFORATION OR RUPTURE. PLEASE NOTE THAT THE MEDWATCH WITH MFR REPORT # 2953161-2019-00029 WAS EMAILED TO FDA TO COVER THE EXPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE DEVICES WERE DEPLOYED AT THE INTENDED POSITION WITH NO REPORTED ISSUES. AN INTRAOPERATIVE ANGIOGRAPHY IDENTIFIED A DISTAL TYPE I ENDOLEAK FROM THE RIGHT SIDE PERTAINING TO THE CONTRALATERAL LEG COMPONENT (PLC201000J/15759404), AND THEREFORE A TOUCH-UP BALLOONING WAS PERFORMED USING A GORE® MOLDING & OCCLUSION BALLOON CATHETER (MOB37/ 20149272) TO REPAIR THE ENDOLEAK. DURING THE BALLOONING, THE PATIENT¿S BLOOD PRESSURE SIGNIFICANTLY DECREASED. RUPTURE OF THE RIGHT EXTERNAL ILIAC ARTERY WAS SUSPECTED. ANOTHER CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO EXTEND THE RIGHT LEG AND COVER THE RUPTURE, AND OPEN SURGERY WAS SIMULTANEOUSLY UNDERTAKEN TO LIGATE THE RIGHT INTERNAL ILIAC ARTERY. ANOTHER ANGIOGRAPHY SHOWED RESOLUTION OF THE RUPTURE, AND THE PROCEDURE WAS CONCLUDED. AS THE ACCESS SITE WAS BEING CLOSED, THE BLEEDING OCCURRED AGAIN FROM THE RUPTURE. THE PHYSICIAN ELECTED TO REPAIR THE RUPTURE SURGICALLY, AND REMOVE THE PLC201000J FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTEDLY ATTRIBUTED THE RUPTURE OF THE RIGHT EXTERNAL ILIAC ARTERY TO THE TOUCH-UP BALLOONING TO REPAIR THE ENDOLEAK. IT WAS ALSO REPORTED THAT THE PATIENT¿S EXTERNAL ILIAC AND INTERNAL ILIAC ARTERIES WERE CALCIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286443 MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES 20149272 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| O| R