BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM - COILTRAC

    MDR report key: 1824757 · Received September 1, 2010

    Report

    Report Number
    2953200-2010-01658
    Event Type
    Injury
    Date Received
    September 1, 2010
    Report Date
    August 2, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (PARALYSIS, ENDOLEAK), (PRE-EXISTING CONDITION WITH DIC, PREVIOUSLY REPLACED AORTIC ARCH CANCER PT), (STENT GRAFT USED WITH AN ARTIFICIAL BLOOD VESSEL).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF 50 MM DIAMETER X 100 MM LONG THORACO-ABDOMINAL ANEURYSM. THE PROXIMAL THORACIC NECK WAS 25 MM IN DIAMETER AND DISTAL THORACIC NECK 30 MM IN DIAMETER. THE PT HAS A HISTORY OF DIC SYNDROME AND REPLACEMENT OF THE AORTIC ARCH WITH AN ARTIFICIAL BLOOD VESSEL. BECAUSE THE PT HAS DIC, THE STENT GRAFT WAS NOT CONNECTED TO THE ARTIFICIAL BLOOD VESSEL DURING IMPLANT. NO ENDOLEAKS WERE OBSERVED DURING THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A TYPE 3 ENDOLEAK WAS DETECTED ON A POST-OPERATIVE CT BETWEEN THE TF2828C116TJ (SEE MFR # 2953200-2010-01657) AND THE TF3434C115TJ; HOWEVER, IT IS UNK IF INTERVENTION WAS PERFORMED. THE TYPE 3 ENDOLEAK HAD DISAPPEARED DURING FOLLOW-UP. FURTHERMORE, THE PT HAD PARAPLEGIA IN BOTH LEGS ON AN UNK DATE (SEE MFR # 2953200-2010-01659). ADDITIONALLY, THE PT HAS DIMINISHED RENAL FUNCTION, AND CANNOT HAVE CT ANGIOGRAPHY; AS THE CREATININE VALUE IS 4. THE PT'S CONDITION ALSO DESCRIBED AS HAVING AN ENCEPHALOPATHIC STATE. FOR DIC, THE VALUES OF FDP & D-DIMMER ARE STILL HIGHER THAN THE STANDARD VALUE. THE PHYSICIAN SUSPECTS THAT DIC IS COMING FROM THE THORACO-ABDOMINAL ANEURYSM. THE PHYSICIAN EXPECTS THE DIC TO RESOLVE AS THE TYPE 3 ENDOLEAK RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. PLEASE NOTE THAT THE (B)(4) IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE TF3434C115CT AND THE TF3434C115X WHICH ARE APPROVED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM - COILTRAC MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00326753

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention