BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2548758 · Received April 25, 2012

    Report

    Report Number
    2953200-2012-00858
    Event Type
    Injury
    Date Received
    April 25, 2012
    Date of Event
    April 2, 2012
    Report Date
    April 2, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION), INCORRECT TECHNIQUE/PROCEDURE (MEASUREMENT AND IMAGING ERRORS). EVALUATION, CONCLUSION: USER ERROR CONTRIBUTED TO EVENT (MEASUREMENT AND IMAGING ERRORS).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7.1 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT WHILE PLACING AN ENDURANT STENT GRAFT SYSTEM, THE PHYSICIAN INADVERTENTLY COVERED THE RIGHT HYPOGASTRIC ARTERY WITH AN EXTENSION TO THE IPSILATERAL LIMB. THE LAO WAS SET AT 60 DEGREES BASED OFF OF THE 3-D RECONSTRUCTION OF THE PATIENT'S ANATOMY. THERE WAS INSUFFICIENT LAO TO SEE THE TAKE-OFF OF THE VESSEL ON THE SHEATH RUN AND THE PHYSICIAN MARKED IT 1.5 CM BEYOND THE HYPOGASTRIC ARTERY. ADDITIONALLY, THE HYPOGASTRIC ARTERY TOOK OFF POSTERIORLY IT WAS NOT RECOGNIZED AT THE TIME OF IMPLANT. ON FINAL ANGIO ALL STENT GRAFTS LOOKED PATENT AND SEALED WITH NO EVIDENCE OF ENDOLEAKS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01010716

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR