BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5610776 · Received April 27, 2016

    Report

    Report Number
    2953161-2016-00070
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    March 31, 2016
    Report Date
    March 31, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. CONCOMITANT PATIENT MEDICATION: ANTI-PLATELET AGENT, STATIN AND AN ACE INHIBITOR.

    Description of Event or Problem · 1

    THE FIELD SALES ASSOCIATE (FSA) REPORTED THAT ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE CONTRALATERAL LEG COMPONENT PXC141000 WAS TRACKED THROUGH A DRYSEAL SHEATH DSL1828, AND THEN ADVANCED OUTSIDE OF THE SHEATH INTO THE IPSILATERAL LEG OF THE MAIN BODY ((B)(4)/UNK). THE SURGEON REPORTEDLY EXPERIENCED DIFFICULTIES WHEN ADVANCING THE PXC COMPONENT AROUND A "BEND" IN THE COMMON ILIAC ARTERY. WHEN ATTEMPTING TO DEPLOY THE PXC141000, THE DEPLOYMENT KNOB WAS UNSCREWED AND PULLED. THE STRING ATTACHED TO THE DEPLOYMENT KNOB HOWEVER 'SNAPPED', LEAVING NO STRING ATTACHED AND THE CONTRALATERAL LEG COMPONENT UNDEPLOYED. THE DECISION WAS MADE TO SLOWLY RETRACT AND THEN REPLACE THE PXC141000 WITH A NEW ONE, BUT THE LEADING END OF THE CATHETER WAS DETACHED FROM THE REST OF THE DELIVERY CATHETER. FOLLOWING NUMEROUS ATTEMPTS TO REMOVE THE PXC COMPONENT WITH VARIOUS SNARE DEVICES, THE SURGEON DECIDED TO COVER THE UNDEPLOYED PXC WITH A LONGER PXC OBTAINING BOTH PROXIMAL AND DISTAL SEAL OVER THE UNDEPLOYED PXC. THE LEADING END OF THE CATHETER REMAINED IN THE PATIENT. THE FINAL RUN SHOWED NO ENDOLEAKS. THE PATIENT TOLERATED THE PROCEDURE. THE REST OF THE CATHETER WAS DISCARDED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268332 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 14564541

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR