BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3667888 · Received March 7, 2014

    Report

    Report Number
    2953200-2014-00429
    Event Type
    Death
    Date Received
    March 7, 2014
    Date of Event
    June 7, 2012
    Report Date
    February 14, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS UNKNOWN. (B)(4). EVALUATION CONCLUSION: OFF-LABEL (IMPLANTING IN ZONE 1).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. RESULTS WITH AN ALGORITHMIC APPROACH TO HYBRID REPAIR OF THE AORTIC ARCH. NICHOLAS D. ANDERSEN, JUDSON B. WILLIAMS, JENNIFER M. HANNA, ASAD A. SHAH, RICHARD L. MCCANN, AND G. CHAD HUGHES. (J VASC SURG 2013;57:655-67.) THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, STOKE, MI, PARALYSIS, RENAL FAILURE, ENDOLEAK, DISSECTION. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. OBJECTIVE: HYBRID REPAIR OF THE TRANSVERSE AORTIC ARCH MAY ALLOW FOR AORTIC ARCH REPAIR WITH REDUCED MORBIDITY IN PATIENTS WHO ARE SUBOPTIMAL CANDIDATES FOR CONVENTIONAL OPEN SURGERY. WE PRESENT OUR RESULTS WITH AN ALGORITHMIC APPROACH TO HYBRID ARCH REPAIR, BASED ON THE EXTENT OF AORTIC DISEASE AND PATIENT COMORBIDITIES. METHODS: BETWEEN (B)(6) 2005 AND (B)(6) 2012, 87 PATIENTS UNDERWENT HYBRID ARCH REPAIR BY THREE PRINCIPAL PROCEDURES: ZONE 1 ENDOGRAFT COVERAGE WITH EXTRA-ANATOMIC LEFT CAROTID REVASCULARIZATION (ZONE 1; N [ 19), ZONE 0 ENDOGRAFT COVERAGE WITH AORTIC ARCH DEBRANCHING (ZONE 0; N [ 48), OR TOTAL ARCH REPLACEMENT WITH STAGED STENTED ELEPHANT TRUNK COMPLETION (STENTED ELEPHANT TRUNK; N [ 20). RESULTS: THE MEAN PATIENT AGE WAS 64 YEARS, AND THE MEAN EXPECTED IN-HOSPITAL MORTALITY RATE WAS 16.3% AS CALCULATED BY THE EUROSCORE II. OF OPERATIONS, 22% (N [ 19) WERE NONELECTIVE. STERNOTOMY, CARDIOPULMONARY BYPASS, AND DEEP HYPOTHERMIC CIRCULATORY ARREST WERE REQUIRED IN 78% (N [ 68), 45% (N [ 39), AND 31% (N [ 27) OF PATIENTS TO ALLOW FOR TOTAL ARCH REPLACEMENT, ARCH DEBRANCHING, OR OTHER CONCOMITANT CARDIAC PROCEDURES, INCLUDING ASCENDING WITH OR WITHOUT HEMIARCH REPLACEMENT IN 17% (N [ 8) OF PATIENTS UNDERGOING ZONE 0 REPAIR. ALL STENTED ELEPHANT TRUNK PROCEDURES (N [20) AND 19% (N [ 9) OF ZONE 0 PROCEDURES WERE STAGED, WITH 41% (N [ 12) OF PATIENTS UNDERGOING STAGED REPAIR DURING A SINGLE HOSPITALIZATION. THE 30-DAY/IN-HOSPITAL RATES OF STROKE AND PERMANENT PARAPLEGIA OR PARAPARESIS WERE 4.6% (N [4) AND 1.2% (N [ 1). OF 27 PATIENTS WITH NATIVE ASCENDING AORTA ZONE 0 PROXIMAL LANDING ZONE, THREE (11.1%) EXPERIENCED RETROGRADE TYPE A DISSECTION AFTER ENDOGRAFT PLACEMENT. THE OVERALL IN-HOSPITAL MORTALITY RATE WAS 5.7% (N [ 5); HOWEVER, 30-DAY/IN-HOSPITAL MORTALITY INCREASED TO 14.9% (N [ 13) OWING TO EIGHT 30-DAY OUT-OF-HOSPITAL DEATHS. NATIVE ASCENDING AORTA ZONE 0 ENDOGRAFT PLACEMENT WAS FOUND TO BE THE ONLY UNIVARIATE PREDICTOR OF 30-DAY IN-HOSPITAL MORTALITY (ODDS RATIO, 4.63; 95% CONFIDENCE INTERVAL, 1.35-15.89; P [ .02). OVER A MEAN FOLLOW-UP PERIOD OF 28.5 ± 22.2 MONTHS, 13% (N [ 11) OF PATIENTS REQUIRED REINTERVENTION FOR TYPE 1A (N [ 4), TYPE 2 (N [ 6), OR TYPE 3 (N [ 1) ENDOLEAK. KAPLAN-MEIER ESTIMATES OF SURVIVAL AT 1 YEAR, 3 YEARS, AND 5 YEARS WERE 73%, 60%, AND 51%. CONCLUSIONS: HYBRID AORTIC ARCH REPAIR CAN BE TAILORED TO PATIENT ANATOMY AND COMORBID STATUS TO ALLOW COMPLETE REPAIR OF AORTIC PATHOLOGY, FREQUENTLY IN A SINGLE STAGE, WITH ACCEPTABLE OUTCOMES. HOWEVER, ENDOGRAFT PLACEMENT IN THE NATIVE ASCENDING AORTA IS ASSOCIATED WITH HIGH RATES OF RETROGRADE TYPE A DISSECTION AND 30-DAY/IN-HOSPITAL MORTALITY AND SHOULD BE APPROACHED WITH CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138820 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death