BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC

    MDR report key: 2870298 · Received December 12, 2012

    Report

    Report Number
    2953200-2012-02419
    Event Type
    Death
    Date Received
    December 12, 2012
    Date of Event
    November 10, 2010
    Report Date
    November 11, 2010
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (CVA/STROKE, DEATH, SURGICAL CONVERSION), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (HIGHLY ANGULATED ANATOMY), INCORRECT TECHNIQUE/PROCEDURE (USE OF DEVICE IN ZONE 1). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (HIGHLY ANGULATED ANATOMY), OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (USE OF DEVICE IN ZONE 1).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4.2 CM THORACIC AORTIC ANEURYSM IN ZONE 1 APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS HIGHLY ANGULATED ANATOMY. THE TEVAR INVOLVED COVERAGE OF THE LCCA, WHICH WAS TO BE PERFUSED VIA A CHIMNEY-UP TECHNIQUE. THE (B)(4) WAS IMPLANTED INTO THE DISTAL SIDE OF THE TAA SUCCESSFULLY WITHOUT ANY ISSUES. THE TALENT THORACIC DEVICE SIZE (B)(4) DELIVERY SYSTEM WAS THEN ADVANCED PROXIMALLY. WHEN THE PHYSICIAN STARTED TO EXPAND THE BARE SPRING, THE BARE SPRING WAS INVERTED TOWARD THE INTERNAL SIDE. THEN, THE PHYSICIAN ATTEMPTED TO PULL BACK THE DELIVERY SYSTEM FOR RECOVERY OF THE INVERTED SPRING BUT COULD NOT. THERE WAS A TYPE I ENDOLEAK PRESENT HOWEVER THE PHYSICIAN WILL MONITOR THE INVERTED BARE SPRING AND TYPE I ENDOLEAK WITHOUT ANY ADDITIONAL TREATMENT AT THE TIME OF THE PROCEDURE. THERE WAS AN OPEN REPAIR INTERVENTION WHEREBY THE STENT GRAFT WAS REMOVED, AND THE ARCH WAS REPLACED WITH THE SYNTHETIC GRAFT. AFTER THE OPEN REPAIR, THE PATIENT HAD A STROKE AND THEN SLIGHT PARAPLEGIA DUE TO THE STROKE. THE PATIENT WAS REPORTED TO BE FINE. THE PHYSICIAN COMMENTED THAT AFTER INITIAL IMPLANT PROCEDURE THE PATIENT WAS ASYMPTOMATIC. THE STROKE WAS RELATED TO THE OPEN SURGERY PROCEDURE. THERE WAS A SLIGHT INJURY TO THE INTIMA, BUT THERE WAS NOT DISSECTION. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO CEREBRAL INFARCTION, THE PHYSICIAN STATED THAT THE DEATH WAS NOT RELATED TO THE STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00541706

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death