BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3042846 · Received March 13, 2013

    Report

    Report Number
    2953161-2013-00038
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE ENGINEERING EVAL WAS PERFORMED ON THE RETURNED PRODUCT WHICH CONSISTED OF THE DELIVERY CATHETER. THE RETURNED DELIVERY CATHETER EXHIBITED BLOOD STAIN, INDICATING THAT THE CATHETER WAS ONCE INSERTED INTO THE PT'S BODY AND RETRACTED. NO ANOMALY WAS OBSERVED ON THE RETURNED DELIVERY CATHETER. THE DEPLOYMENT KNOB AND THE DEPLOYMENT LINE WERE NOT RETURNED, AND THEREFORE, UNAVAILABLE FOR EVAL. BASED ON THE AVAILABLE OBJECTIVE EVIDENCE PROVIDED FROM THE RETURNED PORTION OF THE PRODUCT, THE ENGINEERING EVAL COULD NOT DETERMINE THE CAUSE OF THE DESCRIBED EVENT. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO INCOMPLETE COMPONENT DEPLOYMENT. ADDITIONALLY, THE IFU STATES: DO NOT CONTINUE ADVANCING ANY POTION OF THE DELIVERY SYSTEM IF RESISTANCE IS FELT DURING ADVANCEMENT OF THE GUIDEWIRE, SHEATH, OR CATHETER. STOP AND ASSESS THE CAUSE OF RESISTANCE. VESSEL OR CATHETER DAMAGE MAY OCCUR. LOOSEN THE DEPLOYMENT KNOB. USING FLUOROSCOPY, CONFIRM FINAL DEVICE POSITION AND DEPLOY THE AORTIC EXTENDER USING A STEADY AND CONTINUOUS PULL OF THE DEPLOYMENT KNOB TO RELEASE THE ENDOPROSTHESIS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE DEPLOYMENT OF THE AORTIC EXTENDER COMPONENT THE PHYSICIAN FELT A RESISTANCE AND FORCED THE DEPLOYMENT LINE. THE DEVICE WAS EXTENDED IN THE DISTAL AND CONSTRAINED IN THE PROXIMAL PART. FOR A COMPLETE DEPLOYMENT THE PHYSICIAN USED A CONQUEST BALLOON. THE PT TOLERATED THE PROCEDURE. IT WAS REPORTED TO GORE, THAT DEVICE WAS BROKEN. DURING THE INVESTIGATION AND COMMUNICATION WITH THE PHYSICIAN, THE PHYSICIAN DID NOT CONFIRM IF PART OF THE DEPLOYMENT LINE REMAINED IN THE PT. THE DEPLOYMENT LINE WAS NOT MEASURED BEFORE BEING DISCARDED AT THE HOSP. THE HOSP SENT THE DELIVERY CATHETER WITHOUT DEPLOYMENT KNOB BACK FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106237 GORE EXCLUDER AAA ENDOPROSTHESIS MIH W. L. GORE & ASSOCIATES 9982726

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR