BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

    MDR report key: 8283625 · Received January 28, 2019

    Report

    Report Number
    3007284313-2019-00017
    Event Type
    Injury
    Date Received
    January 28, 2019
    Date of Event
    January 5, 2019
    Report Date
    April 9, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    UDI-DI
    00733132622375
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION EVENT.

    Additional Manufacturer Narrative · 0

    ADDITION UPON FURTHER INVESTIGATION, IT HAS BEEN DETERMINED ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: PLC121200/18199517-UDI (B)(4) AND PLL161407/15983867-UDI (B)(4). THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS WHICH MAY OCCUR AND REQUIRE INTERVENTION INCLUDE OCCLUSION OF THE DEVICE. ADDITION IMAGES WERE SENT TO GORE IMAGING SERVICES FOR EVALUATION. PER THE EVALUATION TWO TIME-POINTS AVAILABLE FOR EVALUATION: PRE-IMPLANTATION CTA DATED (B)(6) 2018, AND POST-IMPLANTATION CTA DATED (B)(6) 2019. ON THE PRE-IMPLANTATION IMAGING; AORTIC DIAMETER AT THE AORTIC BIFURCATION APPEARS TO BE 13.2MM. THERE APPEARS TO BE SIGNIFICANT CALCIUM IN THE LCI. POST-IMPLANTATION CTA IMAGING APPEARS TO SHOW THE IPSILATERAL LIMB IN THE RCI CROSSES OVER THE CONTRALATERAL LIMB WHICH EXTENDS INTO THE LCI. THE CONTRALATERAL LIMB APPEARS TO BE OCCLUDED TO THE DISTAL END OF THE DEVICE IN THE LCI. THERE APPEARS TO BE 2 DEVICES IN THE RCI. THE IPSILATERAL LIMB AND AN ILIAC EXTENDER DEVICE. THE CONTRALATERAL LIMB APPEARS TO BE COMPRESSED NEAR THE LEVEL OF THE AORTIC BIFURCATION. THERE APPEARS TO BE DEVICE OVERLAP IN THE RCI AT THESE LEVELS. CONTRAST IS VISIBLE DISTAL TO THE CONTRALATERAL LIMB IN THE DISTAL LCI, THE LEFT INTERNAL AND EXTERNAL ILIAC ARTERIES. CANNOT CONFIRM ANY DISSECTIONS IN THE LEFT EXTERNAL ILIAC ARTERY OR DISTALLY WITH AVAILABLE IMAGING.

    Description of Event or Problem · 0

    ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT HAD PRESENTED WITH A CLOSED LEFT LIMB OF GORE® EXCLUDER® AAA ENDOPROSTHESES GRAFT. COMPUTED TOMOGRAPHY (CT) DATED (B)(6) 2019, SHOWED A CRUSHED GRAFT AT THE CROSSOVER REGION WITH THE CONTRALATERAL LIMB. ON (B)(6) 2019, THE PHYSICIAN PERFORMED A FEM-FEM BYPASS AND WHEN HE OPENED THE LEFT GROIN, A DISSECTION WAS OBSERVED IN THE LEFT FEMORAL/LEFT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73986 AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 17956028 00733132622375

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R