BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2231137 · Received August 26, 2011

    Report

    Report Number
    2953200-2011-01484
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 24, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: ENDOLEAK.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 34 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE UNK. IT WAS REPORTED THAT IMAGING ACQUIRED APPROXIMATELY 27 MONTHS POST-IMPLANTATION REVEALED NO ENDOLEAKS OR OTHER ISSUES WITH THE STENT GRAFT. APPROXIMATELY 1 MONTH AGO, THE PT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN, AND THE CT REVEALED A FABRIC TYPE III ENDOLEAK JUST ABOVE THE FLOW DIVIDER ON THE LEFT LATERAL WALL OF THE STENT GRAFT. AT THE TIME OF THE ENDOLEAK, THE ANEURYSM WAS 8.4 CM IN DIAMETER, AND THERE WAS NO TORTUOUSITY OR CALCIFICATION IN THE ILIAC ARTERIES. THE ANEURYSM DID NOT RUPTURE, AND THERE WERE NO BREAKS IN THE CONNECTING BAR OR THE STENT RING WHERE THE TYPE III ENDOLEAK WAS LOCATED. THERE WAS ALSO NO DISEASE PROGRESSION, ANGULATION, OR KINKING OF THE DEVICE, AND THEREFORE, THE PHYSICIAN COULD NOT DETERMINE THE CAUSE OF THE TYPE III ENDOLEAK. THE PHYSICIAN ELECTED TO INTERVENE BY IMPLANTING A 26X20X170 TALENT CONVERTER STENT GRAFT AND PERFORMING A FEMORAL-FEMORAL BYPASS, WHICH SUCCESSFULLY RESOLVED THE TYPE III ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FOR THIS CASE. IT WAS REPORTED ON THE DAY OF THE SECONDARY INTERVENTION TO RESOLVE THE PREVIOUSLY REPORTED TYPE III ENDOLEAK, PRE-OPERATIVE DIAGNOSIS REVEALED THAT THE PATIENT HAD CONTAINED RUPTURE. A CT SCAN DONE APPROXIMATELY THREE MONTH AFTER THE SECONDARY INTERVENTION IDENTIFIED SLIGHT ENLARGEMENT OF THE ABDOMINAL AORTIC ANEURYSM, APPROXIMATELY 6 MM. THERE WAS NO ENDOLEAK, MIGRATION OR RUPTURE OBSERVED. THE INVESTIGATOR ASSESSED THE ENLARGEMENT OF THE ABDOMINAL AORTIC ANEURYSM MAYBE RELATED TO TYPE V ENDOLEAK, ENDOTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00188463

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention