BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT

    MDR report key: 3531387 · Received December 20, 2013

    Report

    Report Number
    2953200-2013-02491
    Event Type
    Death
    Date Received
    December 20, 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). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, FISTULA, INFECTION, SEPSIS, DEATH). (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN). EVALUATION CONCLUSIONS: KNOWN INHERENT RISK OF A PROCEDURE (ENDOLEAK, FISTULA, INFECTION, SEPSIS, 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). CASE (B)(4) HISTORY AND OUTCOME: A (B)(6) MALE WITH A PAST MEDICAL HISTORY OF TWO MYOCARDIAL INFARCTIONS HAD PREVIOUSLY BEEN TREATED WITH A BIFURCATED TALENT STENT-GRAFT TO EXCLUDE A 7.5 CM AAA BEGINNING 2.0 CM BELOW THE RIGHT RENAL (MOST DISTAL) ARTERY WITH ASSOCIATED BILATERAL COMMON ILIAC ARTERY ECTASIA. THE ANEURYSM NECK WAS 28 MM IN DIAMETER, AND THE AAA EXTENDED TO THE LEVEL OF THE AORTIC BIFURCATION. ON FOLLOW-UP IMAGING, THE PRESENCE OF EITHER A SMALL TYPE IA OR A PROXIMAL TYPE II ENDOLEAK WAS DEMONSTRATED ON TWO OCCASIONS; HOWEVER, THE AAA SAC DIAMETER REMAINED UNCHANGED. A CLEAR DIFFERENTIATION BETWEEN THESE TWO TYPES OF ENDOLEAKS COULD NOT BE CONFIRMED DESPITE MULTIPLE CT ANGIOGRAMS (CTA) AND SELECTIVE AORTOGRAMS. TWO YEARS LATER, THE PATIENT PRESENTED WITH SEPSIS AND ABDOMINAL PAIN. A CTA ON READMISSION SHOWED AIR BUBBLES WITHIN THE ANEURYSM SAC. AS BOTH THE LENGTH AND THE DIAMETER OF THE INFRARENAL NECK AND THE MAXIMUM DIAMETER OF THE AAA SAC REMAINED UNCHANGED, THE TREATING SURGEON ELECTED TO FOLLOW THIS ASYMPTOMATIC PATIENT. AN AORTO-ENTERIC FISTULA WAS SUSPECTED AND LATER CONFIRMED AT LAPAROTOMY, WITH A COMMUNICATION BETWEEN THE DUODENUM AND THE PRESSU RIZED ANEURYSM SAC. CULTURES REVEALED POLYMICROBIAL FLORA ADJACENT TO THE DEVICE AS WELL AS IN THE BOOD STREAM. THE PATIENT DIED FROM SEPSIS 5 DAYS AFTER REPLACEMENT OF THE STENT-GRAFT WITH AN OPEN SURGICAL REPAIR USING A BIFURCATED POLYESTER GRAFT. TOTAL DURATION OF STENT GRAFT IMPLANTATION WAS 24 MONTHS. OBSERVATION OF THE EXPLANTED STENT-GRAFT: THE STRUCTURE OF THE EXPLANTED DEVICE WAS INTACT. THE WIRES FROM THE PROXIMAL Z-STENTS WERE SECURELY SUTURED TO THE FABRIC. EVALUATION OF THE FABRIC DEMONSTRATED IT TO BE COMPLETELY INTACT. THE STRUCTURE OF THE NITINOL SKELETON PROVED TO BE WELL PRESERVED. THE CONNECTING VERTICAL BARS DID NOT DEMONSTRATE ANY DISTORTION. THE FABRIC OF THE MAIN BODY OF THE GRAFT WAS ALMOST TOTALLY BARE WITH THE ABSENCE OF AN IDENTIFIABLE EXTERNAL CAPSULE ADJACENT TO THE AORTO-ENTERIC FISTULA. THE GRAFT LIMBS WERE ENCAPSULATED AT VARIOUS DEGREES. NO FABRIC DAMAGE WAS IDENTIFIED, AND THE SUTURES HOLDING THE NITINOL WIRE TO THE FABRIC TOGETHER WERE WELL PRESERVED. THE ANGIOSCOPY CONFIRMED THAT THE INTERIOR SURFACE OF THE FABRIC OF THE MAIN BODY WAS NOT ENCAPSULATED AND THAT THE BARE SURFACE WAS EXPOSED TO THE FLOW OF BLOOD. THE PRESENCE OF AN EXTERNAL ENCAPSULATION ORIGINATED AT THE LEVEL OF THE BIFURCATION AND EXTENDED DOWN TO THE DISTAL ASPECT OF THE LIMBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668659 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death| R