BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1884872 · Received October 15, 2010

    Report

    Report Number
    2953200-2010-01967
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS AND CONCLUSIONS: PRE-OPERATIVE RUPTURE, SEVERELY TORTUOUS VESSELS, USE OF THE DEVICE FOR A PRE-OPERATIVE RUPTURED ANEURYSM.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS INSERTED INTO A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF AN 8 CM CONTAINED RUPTURED ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 30-31 MM IN DIAMETER AND 25 MM LONG. THE ILIAC ARTERIES WERE MILDLY CALCIFIED AND SEVERELY TORTUOUS. IT WAS REPORTED THAT THE TALENT BIFURCATED DEVICE WAS ABLE TO BE ADVANCED UP THE LEFT SIDE WITHOUT ISSUES. HOWEVER, WHEN STARTING TO DEPLOY THE DEVICE, BY TURNING THE HANDLE OF THE DELIVERY SYSTEM, THE HANDLE BECAME STUCK, SUCH THAT THE SHEATH COULD NOT BE MOVED IN ORDER TO UNCOVER THE STENT GRAFT. THE STENT GRAFT WAS STILL CONSTRAINED WITHIN THE SHEATH, AND NONE OF THE GRAFT WAS DEPLOYED. THE EVENT WAS LIKELY RELATED TO USER TECHNIQUE AND THE SEVERELY TORTUOUS VESSELS, AS THE DEVICE MAY HAVE BEEN HUGGING THE RIGHT WALL OF THE ANEURYSM/AORTA DUE TO THE SEVERE VESSEL TORTUOSITY. THE DEVICE WAS REMOVED FROM THE PATIENT AND DISCARDED BY THE USER FACILITY. KINKING OF THE GRAFT WITHIN THE SHEATH AROUND THE CONTRALATERAL GATE AREA WAS NOTED. THE PHYSICIAN THEN DECIDED TO USE A 36 MM TALENT BIFURCATED DEVICE, WHICH WAS DELIVERED AND DEPLOYED VIA THE LEFT SIDE WITHOUT ISSUES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00470559

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK