BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1250648 · Received December 3, 2008

    Report

    Report Number
    2953200-2008-01115
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 6, 2008
    Manufacturer
    MEDTRONIC CARDIO VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS & CONCLUSIONS - CHRONICALLY ILL WITH RENAL TRANSPLANT AND IS ON RENAL DIALYSIS, PREVIOUS INTERVENTIONS FOR TYPE 2 ENDOLEAK. OTHER - GRAFT - SUTURE HOLE.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM 6 YEARS AND 8 MONTHS AGO. THE PATIENT WAS CHRONICALLY ILL WITH RENAL TRANSPLANT AND IS ON RENAL DIALYSIS. THE PATIENT HAS ALSO HAD GASTRO INVESTIGATIONS. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT HAD NUMEROUS ADMISSIONS INCLUDING AN INTERVENTION WITH AN ILIAC STENT APPROXIMATELY 2.5 MONTHS POST INITIAL IMPLANT FOR AN UNKNOWN REASON. THE INTERVENTIONS INCLUDED ENDOLEAK CORRECTIONS USING COILS AND GLUE INDICATING THESE WERE MOST LIKELY A TYPE 2 ENDOLEAKS. RECENTLY THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ABDOMINAL PAIN FROM AN UNKNOWN CAUSE AND WAS FOUND TO HAVE A PALPABLE GROWING ANEURYSM SEEN BY CT WITH CONTRAST THAT REVEALED A 15CM ANEURYSM. AN ANGIOGRAM WAS PERFORMED 4 WEEKS AGO TO IDENTIFY IF AN ENDOLEAK IS VISIBLE AND TREATABLE; HOWEVER, THE PHYSICIAN WAS UNABLE TO IDENTIFY ANY ENDOLEAK AT THIS TIME. APPROXIMATELY A WEEK LATER, THE PATIENT WAS SENT FOR OPEN SURGICAL REPAIR. A LAPAROTOMY, ATHERO-ENDARTERECTOMY OF THE ANEURYSM SAC WAS PERFORMED. THIS DETERMINED FLOW WAS DUE TO A TINY SUTURE HOLE AT THE PROXIMAL END OF THE BIFURCATED STENT GRAFT, WHICH ALLOWED A CONSTANT SLOW FLOW TO THE ANEURYSM SAC. THE SUTURE HOLE WAS SEALED WITH A HAEMOSTASIS GEL AND THE ANEURYSM SAC WAS EVACUATED OF THE THROMBUS MATERIAL. THE PATIENT DID WELL, IS FREE OF PAIN, STABLE AND IN SATISFACTORY CONDITION. PLEASE NOTE THAT THIS MODEL NUMBER LYF2816C140 IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE AF2816C140CT WHICH IS APPROVED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIO VASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention