BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 3781450 · Received April 30, 2014

    Report

    Report Number
    2953200-2014-00881
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT IS NO LONGER A MEDWATCH REPORTABLE EVENT. THIS MEDWATCH REPORT IS REDACTED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 24 MM IN DIAMETER, AND THE DISTAL NECK WAS 28 MM IN DIAMETER. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO IMPLANT THE ENDURANT STENT GRAFT DEVICE. THE MAIN BODY WAS INSERTED, AND THE EXTERNAL SLIDER WAS ROTATED FOLLOWING THE NORMAL PROCESS. ALTHOUGH THE SLIDER WAS ROTATED TO THE END, THE GRAFT COVER FAILED TO DEPLOY. DURING DEPLOYMENT, THE PHYSICIAN COMMENTED THAT THEY SENSED THAT SOMETHING BROKE IN THE DELIVERY SYSTEM. THE PHYSICIAN DID NOT KNOW WHAT HAD BROKEN, BUT BELIEVED IT WAS RELATED TO THE DEPLOYMENT DIFFICULTY. NO KINKING OR TWISTING OF THE DELIVERY SYSTEM WAS NOTED DURING THE DEPLOYMENT EFFORTS. THERE WAS REPORTED TO BE NO PROCEDURE DIFFICULTY RELATED TO THE ILIAC ARTERIES, I.E., THEY WERE NOT TORTUOUS OR CALCIFIED. THE DELIVERY SYSTEM WAS REMOVED, AND ANOTHER LONGER STENT GRAFT WAS IMPLANTED WITHOUT INCIDENT. THE PHYSICIAN FELT THAT IN ADDITION TO THE DIFFICULTIES EMPLOYING THE STENT GRAFT, THAT IT WAS ALSO A BIT SHORT FOR THE PATIENT'S ANATOMY, SO A LONGER STENT GRAFT WAS IMPLANTED. A TYPE IA ENDOLEAK WAS NOTED DURING THE PROCEDURE, AND WAS RESOLVED WITH THE PLACEMENT OF AN AORTIC CUFF. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED. THE DEVICE WAS RETURNED FOR ANALYSIS. UPON INSPECTION OF DELIVERY SYSTEM, THERE WAS A BREAK IN THE GRAFT COVER 6 MM FROM THE PROXIMAL END OF THE HEAT AFFECTED ZONE (HAZ); THE HAZ WAS 7 MM IN LENGTH. THE PEBAX AREA ABOVE THE HEAT AFFECTED ZONE WAS SLIGHTLY NECKED. THE BREAK WAS A CLEAN BREAK, WITH NO JAGGED EDGES. THE THUMBWHEEL WAS ADVANCED FORWARD 5 MM AND THE EXTERNAL SLIDER WAS 10 MM FROM THE FRONT GRIP, RESULTING IN AN 10 MM GAP BETWEEN THE BROKEN GRAFT COVER SECTIONS. THERE WAS ALSO A KINK IN THE GRAFT COVER 9.5 CM FROM THE DISTAL END. THE REST OF THE DEVICE WAS UNREMARKABLE. THE WHEEL AND EXTERNAL SLIDER WERE BROUGHT BACK TO THEIR STARTING POSITIONS, WHICH REDUCED THE GAP BETWEEN THE GRAFT COVER SECTIONS TO 1 MM. THE COMPLAINT WAS CONFIRMED; THERE WAS A BREAK IN THE GRAFT COVER JUST PROXIMAL TO THE GRAFT COVER BOND. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IS LIKELY MANUFACTURING RELATED. THE DELIVERY SYSTEM WILL BE SENT TO (B)(4) AND A MANUFACTURING ASSESSMENT WILL BE CREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260168 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04186496

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR