BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX

    MDR report key: 2759283 · Received September 26, 2012

    Report

    Report Number
    9612164-2012-01439
    Event Type
    Death
    Date Received
    September 26, 2012
    Report Date
    August 27, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: INHERENT RISK OF PROCEDURE (DEATH AND MI). (ROOT CAUSE UNDETERMINED, LIMITED INFORMATION). CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (DEATH AND MI). NO CONCLUSION CAN BE DRAWN (ROOT CAUSE UNDETERMINED, LIMITED INFORMATION). (B)(4): "DIFFERENTIAL LONG-TERM OUTCOMES OF ZOTAROLIMUS-ELUTING STENTS COMPARED WITH SIROLIMUS-ELUTING AND PACLITAXEL-ELUTING STENTS IN DIABETIC AND NON-DIABETIC PATIENTS: 2- YEAR SUBGROUP ANALYSIS OF THE ZEST RANDOMIZED TRIAL" THIS ARTICLE HAS BEEN ACCEPTED FOR PUBLICATION AND UNDERGONE FULL PEER REVIEW BUT HAS NOT BEEN THROUGH THE COPYEDITING, TYPESETTING, PAGINATION AND PROOFREADING PROCESS WHICH MAY LEAD TO DIFFERENCES BETWEEN THIS VERSION AND THE VERSION OF RECORD. (B)(4).

    Description of Event or Problem · 1

    THE (B)(6) TRIAL WAS A PROSPECTIVE, RANDOMIZED, SINGLE-BLIND, CONTROLLED STUDY PERFORMED AT 19 CENTERS IN (B)(6) BETWEEN OCTOBER 2006 AND JANUARY 2008. IN BRIEF, THE (B)(6) TRIAL HAD AN 'ALL-COMERS' DESIGN, WITH ELIGIBLE PATIENTS BEING 18 YEARS OR OLDER WITH EITHER STABLE ANGINA OR AN ACUTE CORONARY SYNDROME WITH SIGNIFICANT CORONARY ARTERY DISEASE SUITABLE FOR STENT IMPLANTATION. PATIENTS WERE CONSIDERED TO HAVE DIABETES MELLITUS IF THEY HAD ORAL ANTI-DIABETIC MEDICATIONS, INSULIN TREATMENT, OR HAD CLASSIC SYMPTOMS OF HYPERGLYCEMIA AND RANDOM BLOOD GLUCOSE LEVEL OF 200 MG/DL OR HIGHER. THERE WERE NO LIMITATIONS ON THE NUMBER OF LESIONS OR VESSELS OR ON THE LENGTH OF THE LESIONS. ELIGIBLE PATIENTS WERE RANDOMIZED 1:1:1 TO TREATMENT WITH ZES (ENDEAVOR; MEDTRONIC VASCULAR), SES (CYPHER SELECT; CORDIS, JOHNSON <(>&<)> JOHNSON), OR PES (TAXUS LIBERTE, BOSTON SCIENTIFIC). RANDOMIZATION WAS STRATIFIED BY THE PRESENCE OR ABSENCE OF DIABETES MELLITUS. THE SAME RANDOMLY ASSIGNED STENT HAD TO BE IMPLANTED IN ALL LESIONS IN PATIENTS REQUIRING MULTI-LESION INTERVENTIONS, EXCEPT WHEN THE ASSIGNED STENT COULD NOT BE INSERTED, IN WHICH CASE CROSSOVER TO ANOTHER DEVICE WAS ALLOWED. ALL PATIENTS RECEIVED AT LEAST 100 MG OF ASPIRIN AND A 300- TO 600-MG LOADING DOSE OF CLOPIDOGREL BEFORE OR DURING THE PROCEDURE, AS WELL AS 100 MG/DAY OF ASPIRIN CONTINUOUSLY AND 75 MG/DAY CLOPIDOGREL FOR AT LEAST 12 MONTHS AFTER THE PROCEDURE. THE MAJOR FINDINGS OF THIS ANALYSIS WERE THAT (1) IN DIABETIC PATIENTS, ZES SHOWED SIMILAR 2-YEAR RATES OF MACE COMPARED TO PES, BUT HIGHER RATES OF MACE COMPARED TO SES; (2) IN NON-DIABETIC PATIENTS, THE 2-YEAR RATES OF MACE WERE SIMILAR IN PATIENTS WITH ZES AND SES, BUT WERE SIGNIFICANTLY LOWER WITH ZES THAN WITH PES, AND (3) THERE WAS A SUBSTANTIAL DIABETES RELATED INTERACTION ON MACE OUTCOMES BETWEEN ZES AND SES, BUT NOT BETWEEN ZES AND PES. IN CONCLUSION IN DIABETIC PATIENTS, SES SHOWED THE LOWEST RATE OF MACE COMPARED WITH ZES AND PES. BUT, IN NON-DIABETIC PATIENTS, SES AND ZES SHOWED SIGNIFICANTLY LOWER RATES OF MACE THAN PES. ZES SHOWS A DIABETES-RELATED TREATMENT INTERACTION ON MACE COMPARED WITH SES, BUT NOT COMPARED WITH PES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1