BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT AUI STENT GRAFT

    MDR report key: 2180800 · Received July 22, 2011

    Report

    Report Number
    2953200-2011-01320
    Event Type
    Death
    Date Received
    July 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ANEURYSM RUPTURE, PARAPLEGIA, RENAL FAILURE, INFECTION, DEATH). RESULTS AND CONCLUSIONS: (TYPE II ENDOLEAK).

    Description of Event or Problem · 1

    MEDTRONIC REC'D THE FOLLOWING INFO IN A JOURNAL ARTICLE ENTITLED: "A RANDOMIZED CONTROLLED TRIAL OF ENDOVASCULAR ANEURYSM REPAIR VERSUS OPEN SURGERY FOR ABDOMINAL AORTIC ANEURYSMS IN LOW-TO-MODERATE-RISK PATIENTS" (SOCIETY FOR VASCULAR SURGERY J VASC SURG 2011;53:1167-73). TALENT STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. THE NUMBER OF DEVICES USED AND LOT NUMBERS ARE UNK. SEVERAL STUDIES, INCLUDING THREE RANDOMIZED CONTROLLED TRIALS (RCTS), HAVE SHOWN THAT ENDOVASCULAR REPAIR (EVAR) OF ABDOMINAL AORTIC ANEURYSMS (AAA) OFFERED BETTER EARLY RESULTS THAN OPEN SURGICAL REPAIR (OSR) BUT A SIMILAR MEDIUM-TERM TO LONG-TERM MORTALITY AND A HIGHER INCIDENCE OF RE-INTERVENTIONS. THUS, THE ROLE OF EVAR, MOST NOTABLY IN LOW-RISK PATIENTS, REMAINS DEBATED. METHODS: THE ACE (ANEVRYSME DE L'AORTE ABDOMINALE: CHIRURGIE VERSUS ENDOPROTHESE) TRIAL COMPARED MORTALITY AND MAJOR ADVERSE EVENTS AFTER EVAR AND OSR IN PATIENTS WITH AAA ANATOMICALLY SUITABLE FOR EVAR AND AT LOW-RISK OR INTERMEDIATE-RISK FOR OPEN SURGERY. A TOTAL OF 316 PATIENTS WITH > 5 CM ANEURYSMS WERE RANDOMIZED IN INSTITUTIONS WITH PROVEN EXPERTISE FOR BOTH TREATMENTS: 299 PATIENTS WERE AVAILABLE FOR ANALYSIS, AND 149 WERE ASSIGNED TO OSR AND 150 TO EVAR. PATIENTS WERE MONITORED FOR FIVE YEARS AFTER TREATMENT. STATISTICAL ANALYSIS WAS BY INTENTION TO TREAT. MAJOR ADVERSE EVENTS INCLUDED 3 POST-OP DEATHS AND 26 DURING F/U. DEATHS WERE RELATED TO ANEURYSM OR TREATMENT IN 1 PT AFTER OSR AND IN 6 PATIENTS AFTER EVAR. ONE OSR AND 1 EVAR PATIENTS SUFFERED STROKES; 4 OSR AND 6 EVAR HAD MI; 1 EVAR PT HAD PARAPLEGIA; 1 OSR AND 3 EVAR HAD RENAL FAILURES AND 3 EVAR PATIENTS HAD ANEURYSM RUPTURES. MINOR ADVERSE EVENTS INCLUDED 7 OSR AND 3 EVAR WITH HEMORRHAGE; 11 OSR AND 14 EVAR HAD INFECTION; 3 OSR AND 21 EVAR PATIENTS HAD SUFFERED BUTTOCK CLAUDICATION. IT IS UNK WHICH DEVICE CONTRIBUTED TO WHICH OUTCOME. RESULTS: WITH A MEDIAN F/U OF THREE YEARS (RANGE, 0-4.8 YEARS), THERE WAS NO DIFFERENCE IN THE CUMULATIVE SURVIVAL FREE OF DEATH OR MAJOR EVENTS RATES BETWEEN OSR AND EVAR: 95.9% +/- 1.6% VS 93.2% +/- 2.1% AT ONE YEAR AND 85.1% +/- 4.5% VS 82.4% +/- 3.7% AT THREE YEARS, RESPECTIVELY (P = .09). IN-HOSP MORTALITY (0.6% VS 1.3%; P = 1.0), SURVIVAL, AND THE PERCENTAGE OF MINOR COMPLICATIONS WERE NOT STATISTICALLY DIFFERENT. IN THE EVAR GROUP, HOWEVER, THE CRUDE PERCENTAGE OF RE-INTERVENTION WAS HIGHER (2.4% VS 16%, P < .0001), WITH A TREND TOWARD A HIGHER ANEURYSM-RELATED MORTALITY (0.7% VS 4%; P = .12). CONCLUSIONS: IN PATIENTS WITH LOW TO INTERMEDIATE RISK FACTORS, OPEN REPAIR OF AAA IS AS SAFE AS EVAR AND REMAINS A MORE DURABLE OPTION. (J VASC SURG 2011;53:1167-73.). THE AUTHOR HAS BEEN CONTACTED AND FURTHER INFO HAS BEEN REQUESTED (REF. MFR. # 2953200-2011-01319 AND 01320). THIS EVENT DOES NOT MATCH PREVIOUS EVENTS REPORTED TO MEDTRONIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT AUI STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death