BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVIA STENT GRAFT SYSTEM

    MDR report key: 1790065 · Received August 6, 2010

    Report

    Report Number
    2953200-2010-01519
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    June 3, 2010
    Report Date
    July 9, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A ZONE 3, 6.3 CM SYMPTOMATIC DESCENDING THORACIC AORTIC ANEURYSM 2 MONTHS AGO. THE PATIENT HAS HISTORY OF OPEN AAA REPAIR FROM 10 YEARS AGO. IT WAS REPORTED THAT A SPINAL DRAIN WAS PLACED. THE IMPLANTED STENT GRAFTS WERE MODELED WITH ANOTHER MANUFACTURER'S BALLOON. THE FINAL ANGIOGRAM SHOWED A SMALL PROXIMAL TYPE 1 ENDOLEAK WHICH WAS ADDRESSED BY PLACEMENT OF 1 ADDITIONAL TALENT THORACIC PROXIMAL EXTENSION. THIS WAS IMPLANTED IN ZONE 2 AND BALLOONED. THE LEFT SUBCLAVIAN ARTERY WAS NOT COVERED BY THE STENT GRAFT. AFTER AWAKENING FROM ANESTHESIA, THE PATIENT DEVELOPED AN EXPANDING HEMATOMA IN THE RIGHT GROIN, AND HYPERTENSION WAS ALSO REPORTED AT THIS TIME. THE RIGHT GROIN INCISION WAS RE-OPENED, AND A SMALL HEMATOMA WAS EVACUATED AND THE VESSEL/ADVENTITIA WAS REPAIRED USING PROLENE TO REAPPROXIMATE THE ADVENTITIA. THERE WAS NO FURTHER BLEEDING AND THE INCISION WAS CLOSED. THREE DAYS LATER, ATRIAL FIBRILLATION WAS REPORTED AND ASSOCIATED WITH A RAPID VENTRICULAR RESPONSE AND COMPLAINTS OF PALPITATIONS. INTRAVENOUS AMIODARONE WAS ADMINISTERED, AND THE EVENT WAS NOTED TO BE RESOLVED THE SAME DAY. THE NEXT DAY IT WAS REPORTED THE PATIENT HAD NEUROLOGICAL CHANGES, CITING SLURRED SPEECH AND RIGHT UPPER EXTREMITY WEAKNESS, MILD LEFT PALSY, MILD RIGHT DRIFT, SUBTLE RIGHT HAND CLUMSINESS. A SMALL BRAINSTEM STROKE LIKELY OCCURRED (SEE MFR # 2953200-2010-01520 AND MFR # 2953200-2010-01521). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WAS DISCHARGED TO NURSING FACILITY. CEC ADJUDICATED THAT THE HEMATOMA, NEUROLOGICAL CHANGES, AND ARRHYTHMIA WERE DEVICE AND PROCEDURE-RELATED. PLEASE NOTE THAT THE PRODUCT WITH CATALOG NUMBER TF4646C197C IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE PRODUCT WITH CATALOG NUMBER TF4646C112CT AND TF4646C112X.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00420030

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention