BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2912112 · Received January 11, 2013

    Report

    Report Number
    2953200-2013-00066
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TAPERED SHAPED AORTIC NECK). EVALUATION, CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TAPERED SHAPED AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 51 MM DIAMETER ABDOMINAL AORTIC ANEURYSM AND 17 MM DIAMETER ILIAC ARTERY ANEURYSM APPROXIMATELY EIGHT MONTHS AGO. THE AORTIC NECK WAS TAPERED SHAPED MEASURING 22-27MM AND FROM PROXIMAL TO DISTAL AND 25 MM IN LENGTH. DIAMETER OF THE ILIAC ARTERIES WAS 14 MM BILATERALLY. THE FEMORAL ARTERIES WERE 8 MM IN DIAMETER BILATERALLY. THERE WAS NO PRESENCE OF CIRCUMFERENTIAL THROMBUS OR CALCIFICATION. POST-OP CT IMAGING SHOWED NO ADVERSE EVENTS AND ANEURYSM SIZE WAS 51MM. THE PATIENT WAS DISCHARGED FOUR DAYS POST IMPLANT. A RECENT FOLLOW-UP CT SCAN FROM APPROXIMATELY ONE MONTH AGO SHOWED THE ANEURYSM SIZE WAS 44MM AND CIRCUMFERENTIAL THROMBUS GROWTH AT THE LEVEL OF THE DEVICE WAS REPORTED AND NOTED AS WAS PRESENT AT PREVIOUS FILM READ ON A PREVIOUS UNKNOWN DATE. NO INTERVENTION PERFORMED AND THE PATIENT TO BE MONITORED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEVIED AS FOLLOWS: PER THE INVESTIGATOR THERE WAS CIRCUMFERENTIAL THROMBUS WITHIN THE STENT GRAFT OF THE MAIN BODY. THIS MDR IS REDACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17068 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01043501

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR