BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2974426 · Received February 22, 2013

    Report

    Report Number
    2953200-2013-00331
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 29, 2013
    Report Date
    April 16, 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: INHERENT RISK OF PROCEDURE (DEPLOYMENT DIFFICULTY); CAUSED BY ANOTHER DRUG/DEVICE (SHEATH). CONCLUSION: ANOTHER DEVICE CAUSED FAILURE (SHEATH).

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: CAUSED BY ANOTHER DRUG/DEVICE (SHEATH. CONCLUSION: ANOTHER DEVICE CAUSED FAILURE (SHEATH).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR ILIAC ARTERY ANEURYSM. THE AORTIC NECK DIAMETER WAS 22MM, THE LENGTH WAS 30MM, AND THE NECK ANGLE WAS 60 DEGREES. IT WAS REPORTED THAT DELIVERY SYSTEM WAS POSITIONED AT THE FLOW DIVIDER, BUT THE STENT GRAFT COVER WOULD NOT RETRACT AND ALLOW THE GRAFT TO DEPLOY PROPERLY WHEN THE TRIGGER WAS PULLED. THE PHYSICIAN DISASSEMBLED THE DELIVERY SYSTEM AND THE STENT GRAFT WAS SUCCESSFULLY DEPLOYED MANUALLY. THE PHYSICIAN BELIEVES THE INTERACTION OF THE DELIVERY SYSTEM WITH ANOTHER MANUFACTURER'S SHEATH MAY HAVE KINKED THE DELIVERY SYSTEM. AFTER SUCCESSFULLY IMPLANTING THE STENT GRAFT THE PHYSICIAN REMOVED THE SHEATH, INSERTED THE DISTAL CONTRALATERAL DEVICE WITHOUT A SHEATH, AND DEPLOYED IT WITHOUT ISSUE. NO ADVERSE EVENTS WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    THE DELIVERY SYSTEM WAS RETURNED AND ITS EVALUATION HAS BEEN COMPLETED. THE STENT GRAFT WAS NOT RETURNED AS IT WAS DEPLOYED AND REMAINED IN THE PATIENT. THE DELIVERY SYSTEM WAS RETURNED DISASSEMBLED; ALL EXTERNAL COMPONENTS WERE REMOVED. THE DELIVERY SYSTEM IS WARPED, WITH THREE MAJOR S-BENDS. THE GRAFT COVER IS COMPLETELY SEPARATED IN ONE REGION, WITH TWO REGIONS OF STRETCHING/YIELDING. THE RO MARKER BAND IS CURLED BACK UPON ITSELF. FROM THE DISTAL END OF THE T-TUBE TO THE GRAFT COVER BREAK WAS 22 CM, WHICH MATCHES UP WITH THE END OF THE ENDSEAL HYPOTUBE. ADDITIONALLY, THERE WAS DEFORMATION OF THE GRAFT COVER 15 MM FROM THE END THE DISTAL END OF THE T-TUBE. FROM THE GRAFT COVER BREAK TO THE FIRST AREA OF GRAFT COVER YIELDING/STRETCHING WAS 12 CM, WITH ANOTHER OCCURRING AT 25 CM. EVALUATION OF THE RETURNED DEVICE CONFIRMED THE DELIVERY SYSTEM HAD MAJOR DAMAGE TO THE GRAFT COVER AND A BAILOUT TECHNIQUE WAS USED. THE ROOT CAUSE OF THE DEPLOYMENT DIFFICULTY COULD NOT BE CONFIRMED BASED ON THE STATE OF THE RETURNED DEVICE; HOWEVER, BASED ON THE PHYSICIAN'S REMARKS, THE INTERACTION WITH THE ANOTHER MANUFACTURER'S SHEATH MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78235 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01712622

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR