BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2905698 · Received January 9, 2013

    Report

    Report Number
    2953200-2013-00045
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (SURGICAL CONVERSION TO OPEN REPAIR, ENDOLEAK, ANEURYSM RUPTURE); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (NOT RETURNING FOR FOLLOW-UP, PRE-OPERATIVELY RUPTURED ANEURYSM); INCORRECT TECHNIQUE/PROCEDURE (TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (NOT RETURNING FOR FOLLOW-UP, PRE-OPERATIVELY RUPTURED ANEURYSM); OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM).

    Description of Event or Problem · 1

    A TALENT AND ANEURX STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8 CM PRE-OPERATIVELY RUPTURED ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 32 MONTHS AGO. VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WAS NOT REPORTED. CURRENT ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN. THE PATIENT WAS INITIALLY TREATED WITH A TALENT BIFURCATED STENT GRAFT AND THREE ANEURX ILIAC STENT GRAFTS. IT WAS REPORTED THAT PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN APPROXIMATELY ONE MONTH AGO AND THE ANEURYSM WAS FOUND TO HAVE RUPTURED DUE TO A TYPE II OR TYPE III ENDOLEAK. THE PHYSICIAN DECIDED TO CONVERT THE PATIENT TO OPEN REPAIR AND EXPLANTED THE DEVICES. THE TALENT BIFURCATED STENT GRAFT PROXIMAL BARE SPRINGS WERE CUT FROM THE GRAFT AND LEFT IN THE PATIENT. IT IS UNKNOWN IF THE PATIENT RETURNED FOR ROUTINE FOLLOW UP APPOINTMENTS. NO ADDITIONAL CLINICAL SEQUELAE REPORTED AND THE PATIENT WAS STABLE. THE EXPLANTED STENT GRAFTS WERE RETAINED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12003 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention