BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 12274924 · Received August 4, 2021

    Report

    Report Number
    3007284313-2021-01532
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 7, 2021
    Report Date
    March 29, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132650965
    PMA / PMN Number
    P200030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE EVALUATION PERFORMED BY ENGINEERING SHOWED THE FOLLOWING: ¿ THE LEADING TIP WAS NOT ATTACHED TO THE LEADING END OF THE RETURNED DEVICE CATHETER. ¿ NEITHER THE LEADING TIP NOR THE LOCATION ON THE CATHETER WHERE THE TIP WOULD BE BONDED SHOWED ANY MATERIAL REFLOW OR SIGNS OF BONDING, WHICH IS CONSISTENT WITH A LACK OF BOND OR AN INSUFFICIENT BOND BETWEEN THE LEADING TIP AND CATHETER. ¿ NO DAMAGE WAS IDENTIFIED TO TIP AND THE PROXIMAL END OF THE CATHETER. BASED ON THE FINDINGS FROM THE EVALUATION, THE CONDITION OF THE RETURNED DEVICE IS CONSISTENT WITH THE PHYSICIAN¿S OBSERVATION THAT THE ¿LEADING OLIVE SEPARATE[D] FROM THE CATHETER¿. EVIDENCE OF INSUFFICIENT BONDING BETWEEN THE LEADING TIP AND CATHETER WAS OBSERVED, AND THE GREATEST SEVERITY OF HARM FOR THIS FAILURE MODE DOCUMENTED IN THE CONFORMABLE EXCLUDER (CEXC) PROCESS FAILURE MODES AND EFFECTS ANALYSIS (PFMEA) ((B)(4)) REVISION 17 IS ¿CRITICAL¿. THEREFORE, CAPA REQUEST OR134922, WHICH CAPTURES THIS EVENT, WAS GENERATED PER MD145952 REVISION 22, BUT CAPA101692 CURRENTLY EXISTS AND ADDRESSES THE OCCURRENCE OBSERVED IN THIS EVENT. CORRECTED DATA: H6: COMPONENT CODE, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION CODES ADDED

    Additional Manufacturer Narrative · 0

    G4:P200030. H1/H2: CORRECTION. H10/11: CORRECTED G4.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING IMPLANTATION OF A GORE® EXCLUDER® AAA CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS, THE LEADING OLIVE BECAME DISLODGED FROM THE DELIVERY CATHETER INSIDE THE PATIENT. THE OLIVE WAS SUCCESSFULLY RETRIEVED. THERE WAS NO KNOWN RESISTANCE DURING ADVANCEMENT OR WITHDRAW OF THE DELIVERY CATHETER. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172870 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. CXA320005 00733132650965

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown