BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3129638 · Received May 24, 2013

    Report

    Report Number
    2953200-2013-00988
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY RUPTURED ANEURYSM); UNAPPROVED USE OF DEVICE (TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM). CONCLUSION: INHERENT RISK OF PROCEDURE (ENDOLEAK); DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY RUPTURED ANEURYSM); OFF ¿LABEL, UNAPPROVED OR CONTRAINDICATED USE (TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A PRE-OPERATIVELY RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER THE STENT GRAFTS WERE IMPLANTED THERE WAS AN ENDOLEAK WHICH WAS THOUGHT TO BE COMING THROUGH THE STENT GRAFT. ALL SEAL AREAS AND STENT GRAFT OVERLAP AREAS WERE RE-BALLOONED. THEN THE BALLOON WAS PLACED AND INFLATED IN THE BODY OF THE STENT GRAFT AND THE ENDOLEAK WAS STILL PRESENT WHICH CONFIRMED THAT THE ENDOLEAK WAS NOT A PROXIMAL TYPE I ENDOLEAK. BOTH LIMBS WERE RELINED WITH AN ENDURANT 161393 AND 161693 AND THE ENDOLEAK WAS SUCCESSFULLY RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232340 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04005840

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention