BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT

    MDR report key: 3536723 · Received December 24, 2013

    Report

    Report Number
    2953200-2013-02536
    Event Type
    Death
    Date Received
    December 24, 2013
    Date of Event
    November 4, 2011
    Report Date
    December 2, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS, CONCLUSIONS: INHERENT RISK OF PROCEDURE (MIGRATION, ENDOLEAK, ANEURYSM RUPTURE, DEATH). INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. DETAILED ANALYSIS OF A SERIES OF EXPLANTED TALENT AAA STENT-GRAFTS: BIOFUNCTIONALITY ASSESSMENT. MARK NUTLEY, ROBERT GUIDOIN, TIEYING YIN, YVAN DOUVILLE, ZE ZHANG, GEORGI MARINOV, DANGHENG WEI, JING LIN, BENEDIKT WEBER, LU WANG, BIN LI, GREGORY SAMISB, YAHYE MERHI, ROBERT MCGREGOR, GUY DIONNE, NATHALIE GILBERT. (JOURNAL OF LONG-TERM EFFECTS OF MEDICAL IMPLANTS, 21(4): 299 ¿ 319; 2011). (B)(6) HISTORY AND OUTCOME: AN (B)(6) MALE PATIENT WITH A REMOTE HISTORY OF SUCCESSFUL TREATMENT OF (B)(6), AND COMPLETE RECOVERY FROM TWO MINOR STROKES, WAS DIAGNOSED WITH A 6.9 CM AAA. A TALENT MODULAR STENT-GRAFT WAS DEPLOYED WITHOUT COMPLICATION, AND THE PATIENT RECOVERED FULLY. THREE YEARS LATER, THE PATIENT RECEIVE A QUADRUPLE CORONARY BYPASS. AT THIS TIME, A THORACO-ABDOMINAL CTA DEMONSTRATED THAT THE DIAMETER OF THE ABDOMINAL ANEURYSM HAD INCREASED TO 7.7 CM AND AN ASYMPTOMATIC TYPE IB ENDOLEAK OF THE LEFT LIMB WAS NOTED; IT WAS OBSERVED FLOATING FREELY IN THE COMMON ILIAC ARTERY ANEURYSM SAC. THE PATIENT WAS DISCHARGED TO A CARDIAC REHABILITATION CENTER POST CORONARY BYPASS GRAFTING (CABG) WITH THE PLAN TO CORRECT THIS ENDOLEAK ON A SEMI-URGENT BASIS. THREE WEEKS AFTER THE CABC, THE PATIENT WAS ADMITTED IN SEVERE SHOCK CAUSED BY RUPTURE OF THE PRESSURIZED AAA SAC. THE TREATING SURGEON ELECTED TO EXPLANT THE ENTIRE STENT-GRAFT, AND AN EMERGENCY OPEN AORTO-BIILIAC RECONSTRUCTION WAS PERFORMED. THE PATIENT DIED FROM MEDICAL COMPLICATIONS FROM THE PROCEDURE 3 DAYS POSTOPERATIVELY. TOTAL DURATION OF STENT GRAFT IMPLANTATION WAS 36 MONTHS. OBSERVATION OF THE EXPLANTED STENT-GRAFT: THE DEVICE EXPLANTED FROM (B)(6) APPEARS TO HAVE ULTIMATELY RESULTED FROM A TYPE 1B ENDOLEAK AT THE DISTAL LEFT LIMB. HOWEVER, POST-EXPLANTATION ANALYSIS ALSO REVEALED A NUMBER OF STRUCTURAL DEVICE FAILURES WHICH MAY HAVE CONTRIBUTED TO THIS PATIENT¿S DEATH. FIRSTLY, THERE WAS CLEAR EVIDENCE OF RUPTURE OF THE THIN PROXIMAL EXTERNAL SUPPORT WIRE AT THE DOCKING ZONE. THE EXTREMITY OF THIS WIRE WAS NO LONGER ANCHORED TO THE FABRIC. ALSO, SIGNIFICANT HOLES MEASURING MORE THAN 4 MM2 WERE OBSERVED IN THE FABRIC AT THE LEVEL OF THE BIFURCATION BETWEEN THE MAIN BODY AND THE IPSILATERAL LIMB MIDWAY BETWEEN TWO ADJACENT Z-STENTS. THESE APEXES APPEARED TO HAVE COME IN CONTACT WITH EACH OTHER DURING EACH REPETITIVE CARDIAC PULSE, CAUSING GRADUAL DESTRUCTION TO THE FABRIC AND PRESSURIZATION OF THE AAA SAC, LEADING TO DISRUPTION OF THE DISTAL SEAL ZONE. THE PHYSIOLOGICAL SIGNIFICANCE OF THIS FABRIC DEFECT WAS CONFIRMED BY EX VIVO CPS USING A COLORED GLYCEROL SOLUTION. THERE WAS MINIMAL EXTERNAL ENCAPSULATION THE GRAFT, AND THE EXTERNAL SURFACE WAS IRREGULARLY COATED WITH SCATTERED FRESH THROMBI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673964 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death| R