BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3150941 · Received June 6, 2013

    Report

    Report Number
    2953200-2013-01085
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    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), RESULTS: INHERENT RISK OF PROCEDURE (DEPLOYMENT DIFFICULTY), UNAPPROVED USE OF DEVICE (NECK DIAMETER <(><<)>19MM), (LACK OF INFORMATION, CAUSE OF EVENT IS UNKNOWN), CONCLUSION: INHERENT RISK OF A PROCEDURE (DEPLOYMENT DIFFICULTY), (LACK OF INFORMATION, CAUSE OF EVENT IS UNKNOWN), OFF¿LABEL, UNAPPROVED OR CONTRAINDICATED USE (NECK DIAMETER <(> <<)>19MM).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 56 X 51MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 18.5 MM IN DIAMETER AND 11 MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 12 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 12 MM IN DIAMETER. THE RIGHT EXTERNAL ILIAC ARTERY MEASURED 8 MM IN DIAMETER AND THE LEFT EXTERNAL ILIAC ARTERY MEASURED 8.5 MM IN DIAMETER. IT WAS REPORTED THAT AFTER MAIN BODY AND CONTRALATERAL LIMB WERE SUCCESSFULLY IMPLANTED, A DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) FOUND A POSSIBLE TYPE I OR IV ENDOLEAK. THE CAUSE OF THE ENDOLEAK IS UNKNOWN AND AN AORTIC CUFF WAS IMPLANTED IN AN ATTEMPT TO RESOLVE THE ENDOLEAK. IT WAS CONFIRMED THERE WAS A TYPE IV ENDOLEAK, BLUSH WHICH WAS LEFT UNTREATED. THE CUFF WAS PLACED AT THE POSITION OF THE MAIN BODY PROXIMAL MARKER. IN ADDITION, THERE WAS DIFFICULTY DEPLOYING THE AORTIC CUFF LEADING TO AN INACCURATE DEPLOYMENT; THE DISTAL SIDE OF THE AORTIC CUFF APPEARED STUCK ON BARE STENT OF THE CONTRALATERAL LIMB. AFTERWARDS, THE PULSE WAS WEAK AT THE LEFT LEG. TOUCH UP BY A BALLOON CATHETER WAS ATTEMPTED TO RESOLVE THE INACCURATE CUFF DEPLOYMENT, HOWEVER IT WAS NOT RESOLVED. THE PHYSICIAN DECIDED TO PERFORM A FEMORAL-FEMORAL BYPASS TO RESOLVE THE INACCURATE DEPLOYMENT. THE FEMORAL-FEMORAL BYPASS WAS SUCCESSFUL. THE PHYSICIAN WILL MONITOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250434 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01693222

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention