BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2951071 · Received February 8, 2013

    Report

    Report Number
    2953200-2013-00223
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, ANEURYSM RUPTURE, STENT FRACTURE); LACK OF INFORMATION (UNKNOWN CAUSE OF CONNECTING BAR FRACTURE). CONCLUSION: LACK OF INFORMATION (UNKNOWN CAUSE OF CONNECTING BAR FRACTURE).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE YEARS AGO. IT WAS REPORTED THAT THREE WEEKS AGO THE PATIENT WAS TRANSPORTED TO THE HOSPITAL (B)(6) 2013 WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE CT SCAN SHOWED THE ANEURYSM DIAMETER HAD INCREASED TO 10 CM, AND THERE WAS CONTRAST IN THE ANEURYSM SAC AROUND THE AREA OF THE FLOW DIVIDER. A CUT DOWN ON THE RIGHT WAS PERFORMED FOLLOWED BY INFLATION OF A RELIANT BALLOON UP TO THE GATE. CONTRAST WAS INJECTED FROM THE TOP WHICH SHOWED AN ENDOLEAK AROUND THE FLOW DIVIDER. THE BALLOON WAS THE PLACED IN THE MAIN BODY AND DID AN ISOLATED LIMB INJECTION WHICH DID NOT SHOW THE ENDOLEAK. THE PHYSICIAN DETERMINED THAT THE ENDOLEAK MAY BE A PROXIMAL TYPE 1 ENDOLEAK; THEREFORE A 32 X 32 X 49 ENDURANT CUFF WAS PLACED. AFTER BALLOONING AN INJECTION WAS DONE AND STILL SHOWED THE ENDOLEAK. AT THIS POINT BOTH LIMBS WERE RELINED; HOWEVER, BUT THE ENDOLEAK WAS STILL PRESENT. IT WAS ALSO NOTED THAT THE TALENT LIMBS WERE CROSSED AND THERE APPEARED TO BE A CONNECTING BAR FRACTURE OF THE BIFURCATED STENT GRAFT. A 32 MM DIAMETER TALENT CONVERTER WAS PLACED FROM THE RIGHT SIDE AND AN 18 MM AMPLATZER PLUG ON THE LEFT SIDE. AFTER BALLOONING THE ENDOLEAK WAS FOUND TO HAVE SUCCESSFULLY RESOLVED AND NO BLOOD FLOW WAS GOING DOWN THE LEFT LIMB. A RIGHT TO LEFT FEM-FEM BYPASS WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53960 TALENT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00193001

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention