BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2974531 · Received February 22, 2013

    Report

    Report Number
    2953200-2013-00339
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TORTUOUS ANATOMY). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TORTUOUS ANATOMY).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70 MM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE AORTIC NECK WAS 29MM LONG, AND 25-36MM IN DIAMETER. THE RIGHT COMMON ILIAC WAS 10-8MM IN DIAMETER AND THE RIGHT WAS 9MM IN DIAMETER. IT WAS REPORTED THAT THE FIRST TWO DEVICES WERE SUCCESSFULLY IMPLANTED. AFTER THE DISTAL CONTRALATERAL LIMB WAS DEPLOYED THE GRAFT COVER WOULD NOT EXTEND ALL THE WAY TO THE TIP. A GAP OF APPROXIMATELY 5MM REMAINED WHICH WAS NOT PRESENT PRIOR TO USE. THE PHYSICIAN BELIEVES THIS WAS DUE TO THE TORTUOUS ANATOMY OF THE VESSEL AT THE DELIVERY SITE WHICH CAUSED THE DELIVERY SYSTEM TO BE CURVED MORE THAN USUAL. THERE WERE NO COMPLICATIONS IN STENT GRAFT DEPLOYMENT AND THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE AND THE PATIENT IS FINE. THE PHYSICIAN WAS ABLE TO CLOSE THE GAP AFTER THE DELIVERY SYSTEM WAS REMOVED FROM THE SHARPLY CURVED AREA. THE DEVICE WAS RETURNED BENT WITHIN A PLASTIC BAG WITHIN A SQUARE BOX. THE DEVICE WAS RETURNED BLOODIED. UPON INSPECTION OF THE DELIVERY SYSTEM THERE WAS A SMALL GAP THAT MEASURED JUST OVER 1MM BETWEEN THE GRAFT COVER AND TAPERED TIP. THIS MEASUREMENT WAS TAKEN WITH THE GRAFT COVER BEING CURVED WITH 2 SMALL KINKS. THERE WAS A KINK IN THE GRAFT COVER JUST DISTAL TO THE STRAIN RELIEF AND ANOTHER KINK JUST DISTAL TO THE STENT STOP, 134MM FROM THE DISTAL END OF THE TAPERED TIP. AFTER STRAIGHTENING THE GRAFT COVER, THE GAP BETWEEN THE GRAFT COVER AND TAPERED TIP WAS REDUCED TO LESS THAN 1 MM. WHEN THE GRAFT COVER WAS PUSHED FORWARD SLIGHTLY THE GAP WAS COMPLETELY GONE. THE COMPLAINT COULD NOT BE CONFIRMED, SINCE THE EVENT TOOK PLACE IN VIVO. THE RETURNED DELIVERY SYSTEM HAD DEFORMATIONS TO THE GRAFT COVER THAT ARE TO BE EXPECTED AFTER USE IN A TORTUOUS ANATOMY AND AFTER BEING SHIPPED IN A SQUARE BOX. THE ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED; HOWEVER IS POTENTIALLY DUE TO THE TORTUOUS ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78666 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01126960

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR