BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 11036153 · Received December 18, 2020

    Report

    Report Number
    3007284313-2020-01203
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    September 3, 2019
    Report Date
    October 19, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6-4112: THE EXPLANTING HOSPITAL SENT THE EXPLANTS TO A THIRD PARTY FOR INVESTIGATION. THEY SHARED THEIR LEVEL 1 INVESTIGATION REPORT WITH W. L. GORE & ASSOCIATES INC.. THE REPORT WAS REVIEWED BY W. L. GORE & ASSOCIATES INC.. H6-213: THE EXPLANT REPORT REVIEW SUMMARY STATES THE FOLLOWING: TISSUE PRESENT: YES. MINIMAL, SCATTERED PLAQUES OF FRIABLE RED BROWN MATERIAL VISIBLE ON THE ABLUMINAL SURFACE. LUMENS WERE REPORTED ¿CLEAR¿ HOWEVER, PATENCY COULD NOT BE CONFIRMED WITH THE IMAGES PROVIDED. THERE WAS A THIN LAYER OF TAN/BROWN TISSUE ON THE ABLUMEN OF THE PROXIMAL TRUNK. THE GORE® EXCLUDER® AAA ENDOPROSTHESES REMAINED IN THE OVERLAPPING CONFIGURATION. TWO CONTRALATERAL LEG EXTENDED FROM THE CONTRALATERAL GATE. THE TRUNK¿S CONSTRAINED SLEEVE WAS CUT, AND THE PROXIMAL PORTION DOES NOT APPEAR TO HAVE BEEN RETURNED; IT REMAINED ATTACHED AT THE DISTAL END OF THE IPSILATERAL LEG. THE CONSTRAINT SLEEVE CUT WAS CONSISTENT WITH MANUAL MANIPULATION AT TIME OF EXPLANT VIA SURGICAL INSTRUMENTATION (I.E., SCALPEL, SCISSORS). THE CONSTRAINT SLEEVE CUT WAS CONSISTENT WITH MANUAL MANIPULATION AT TIME OF EXPLANT VIA SURGICAL INSTRUMENTATION (I.E., SCALPEL, SCISSORS). THE ¿KINK¿ NOTED BY THIRD PARTY APPEARED TO BE CONSISTENT WITH THE DEVICE REMAINING IN A CURVED POSITION (I.E., SIGHT OF ANATOMICAL BEND). REQUEST FOR ADDITIONAL ANALYSIS: NO . REASON: BASED ON REVIEW OF THE THIRD PARTY REPORT, NO ADDITIONAL ANALYSIS IS REQUESTED. BASED ON THE EVENT DESCRIPTION AND THE SUBSEQUENT INVESTIGATION, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    REQUESTS FOR ADDITIONAL INFORMATION WERE SENT TO THE THIRD PARTY. THE ANSWERS WERE INCLUDED IN THE EVENT DESCRIPTION. ONLY LIMITED PATIENT DATA COULD BE PROVIDED BECAUSE OF PRIVACY REASONS. THE SERIAL NUMBER OF THE DEVICE COULD NOT BE OBTAINED. THE SERIAL NUMBER OF THE DEVICE REMAINS UNKNOWN. THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. THE EXPLANTING HOSPITAL SENT THE EXPLANTS TO A THIRD PARTY FOR INVESTIGATION (GEPROVAS). GEPROVAS SHARED THEIR LEVEL 1 INVESTIGATION REPORT WITH GORE. THE REPORT IS BEING REVIEWED BY GORE. OTHER CODE: THE MEDICAL DEVICE WAS RETURNED BY THE USER TO A THIRD PARTY FOR EVALUATION. THE LEVEL 1 ANALYSIS REPORT WAS SHARED WITH GORE. THE REPORT IS BEING REVIEWED AND EVALUATED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE PATIENT WAS TREATED FOR AN ASYMPTOMATIC, NON-COMPLICATED ANEURYSM OF THE ABDOMINAL AORTA WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE IMPLANTED ENDOPROSTHESIS CONSISTED OF A TRUNK - IPSILATERAL LEG ENDOPROSTHESIS (RLT), A CONTRALATERAL LEG ENDOPROSTHESIS (PLC) AND AN ILIAC EXTENDER ENDOPROSTHESIS (PLL). ON (B)(6) 2019, THE PATIENT WAS DIAGNOSED AN INFECTION TO STAPHYLOCOCCUS LUGDUNENSIS AND AN ANTIBIOTICS THERAPY WAS PERFORMED. TO DIAGNOSE AND CONFIRM THIS INFECTION, SCINTIGRAPHY TO GRANULOCYTE WAS PERFORMED. IN (B)(6) 2019 THE PATIENT WAS AGAIN DIAGNOSED AN INFECTION TO STAPHYLOCOCCUS LUGDUNENSIS AND AGAIN AN ANTIBIOTICS THERAPY WAS PERFORMED. THEY STATED THAT THE INFECTION WAS MOST PROBABLE CAUSED BY PERIPROCEDURAL INFILTRATION/COLLECTION DURING THE INITIAL PROCEDURE. ANTIBIOTICS WERE ADMINISTERED FOR 6 MONTHS WITHOUT SUCCESS. ON (B)(6) 2019, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS EXPLANTED DUE TO AN INFECTION. BIOLOGICAL PROBES WERE TAKEN ON THE DEEP OPERATIVE WOUND, ON THE EXPLANTS, ON TISSUE AROUND THE EXPLANTS AND ON THE NATIVE AORTA ARTERY AND THESE PROBES WERE TESTED POSITIVE TO STAPHYLOCOCCUS LUGDUNENSIS. THEY REPORTED THAT THE SEPTIC CONTEXT IS GETTING BETTER, BUT THE PATIENT HAS DEVELOPED A PHLEBITIS. THE PATIENT IS GENERALLY DOING WELL; HE HAS NO PAIN AND THE SCARPA´S FASCIA IS CLEAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500360 GORE EXCLUDER AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization