BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 2883971 · Received December 21, 2012

    Report

    Report Number
    2953200-2012-02469
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHODS: (FILM); RESULTS: INHERENT RISK OF PROCEDURE (INACCURATE DELIVERY); INCORRECT TECHNIQUE/PROCEDURE (INACCURATE PLACEMENT OF STENT GRAFT). CONCLUSION: DEVICE FAILURE RELATED TO USER HANDLING (INACCURATE PLACEMENT OF STENT GRAFT).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL AND ANEURYSM MORPHOLOGY AT IMPLANT ARE UNKNOWN. THE PATIENT PRESENTED EMERGENTLY WITH PAIN. A CT REVEALED THE PATIENT HAD LEFT LIMB OCCLUSION ALL THE WAY UP TO THE BIFURCATED STENT GRAFT. THE PHYSICIAN PERFORMED AN OVER THE WIRE THROMBECTOMY. THE DISTAL FLOW IN THE EXTERNAL ILIAC WAS POOR DUE TO TORTUOSITY AND CALCIFICATION. THE POSSIBLE CAUSE WAS DUE TO THE ENDURANT CUFF BEING DEPLOYED TOO LOW (IN THE FLOW DIVIDER) WHICH OCCLUDED THE GRAFT OR SOMEHOW OCCLUDED LEFT SIDE DUE TO INADEQUATE SEALING. SO, THE PHYSICIAN BALLOONED THE CUFF AND PLACED AN (B)(4) 2 CM ABOVE BIFURCATED STENT GRAFT REPAIRED THE LEFT ILIAC WITH (B)(4) AND (B)(4) CONTRALATERAL LIMBS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. SINGLE RETURNED IMAGE POST- SECONDARY SHOW THAT THE IPSILATERAL LIMB WAS PLACED INTO THE RIGHT ILIAC; CROSSING OVER THE CONTRA LIMB. BOTH LIMBS APPEAR TO HAVE BEEN RELINED FROM ABOVE THE BIFURCATE FLOW DIVIDER TO THE DISTAL END OF THE LIMBS. NO OBVIOUS STENT GRAFT OCCLUSION IS SEEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention