BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT BIFURCATED STENT GRAFT

    MDR report key: 2852949 · Received November 30, 2012

    Report

    Report Number
    2953200-2012-02289
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (INACCURATE DELIVERY, OCCLUSION). (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 67 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 29.5 MM IN DIAMETER AND 48 MM IN LENGTH. THE RIGHT ILIAC ARTERY WAS 17.8 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 17 MM IN DIAMETER. THERE WAS NO DIFFICULTY INSERTING THE DELIVERY SYSTEMS. IT WAS REPORTED THAT INTRA-OPERATIVELY, AFTER THE MAIN BODY WAS DEPLOYED, THE PHYSICIAN PULLED THE DELIVERY SYSTEM BACK AND THE NOSE CONE CAUGHT ON THE SUPRA-RENAL STENT. THE PHYSICIAN WAS TRYING TO REMOVE THE DELIVERY SYSTEM; HOWEVER, THE SUPRA-RENAL STENT ROLLED INWARD. THE TIP CAPTURE WAS SUCCESSFULLY DONE ABOVE THE SUPRARENAL STENTS. THE PHYSICIAN COMPLETED THE DEPLOYMENT OF THE CONTRALATERAL LIMB AND INSERTED A CODA BALLOON FROM THE CONTRALATERAL SIDE. THERE WAS NO DIFFICULTY RETRACTING THE NOSECONE INTO THE GRAFT COVER. THE PHYSICIAN PERFORMED TOUCH-UP WITH THE BALLOON ON THE PROXIMAL AORTIC NECK AND PULLED OUT THE DELIVERY SYSTEM SUCCESSFULLY. THE SUPRA-RENAL STENT WAS STILL ROLLED INWARD AND THE PHYSICIAN TRIED TO PUSH IT BACK USING A BALLOON. A SUPER STIFF WIRE WAS USED IN THE CASE. ON FINAL ANGIOGRAM, THE PHYSICIAN CONFIRMED THERE WAS NO ENDOLEAK AND FINISHED THE PROCEDURE. AFTER THE PROCEDURE, THE PHYSICIAN FOUND ON 3D IMAGES THAT THE THREE SUPRA-RENAL STENTS WERE ENTANGLED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01099929

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR