BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 4146796 · Received October 7, 2014

    Report

    Report Number
    9612164-2014-01279
    Event Type
    Death
    Date Received
    October 7, 2014
    Date of Event
    June 23, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS: (BASED ON THE INFORMATION AVAILABLE NO ROOT CAUSE CAN BE DETERMINED). (DEATH). (NO DEVICE RECEIVED FOR EVALUATION). (NO DEVICE RECEIVED FOR EVALUATION). (B)(4) JOURNAL ARTICLE TITLE: REVASCULARISATION VERSUS MEDICAL TREATMENT IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE: NETWORK META-ANALYSIS - BMJ 2014;348:G3859 DOI: 10.1136/BMJ.G3859 (PUBLISHED 23 JUNE 2014) HTTP://WWW.BMJ.COM/SUBSCRIBE PTS AGE: AGE AT TIME OF EVENT IS THE AVERAGE AGE OF PATIENTS. EVENT DATE = DATE OF PUBLICATION. DATE OF DEATH IS THE MIDPOINT BETWEEN THE MEDLINE AND EMBASE SOURCES (1980 TO 2013 FOR RANDOMISED TRIALS COMPARING MEDICAL TREATMENT WITH REVASCULARIZATION).

    Description of Event or Problem · 1

    OBJECTIVE: TO INVESTIGATE WHETHER REVASCULARISATION IMPROVES PROGNOSIS COMPARED WITH MEDICAL TREATMENT AMONG PATIENTS WITH STABLE CORONARY ARTERY DISEASE. DESIGN: (B)(4) NETWORK META-ANALYSES TO COMBINE DIRECT WITHIN TRIAL COMPARISONS BETWEEN TREATMENTS WITH INDIRECT EVIDENCE FROM OTHER TRIALS WHILE MAINTAINING RANDOMISATION. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: A STRATEGY OF INITIAL MEDICAL TREATMENT COMPARED WITH REVASCULARISATION BY CORONARY ARTERY BYPASS GRAFTING OR FOOD AND DRUG ADMINISTRATION APPROVED TECHNIQUES FOR PERCUTANEOUS REVASCULARIZATION: BALLOON ANGIOPLASTY, BARE METAL STENT, EARLY GENERATION PACLITAXEL ELUTING STENT, SIROLIMUS ELUTING STENT, AND ZOTAROLIMUS ELUTING (ENDEAVOR) STENT, AND NEW GENERATION EVEROLIMUS ELUTING STENT, AND ZOTAROLIMUS ELUTING (RESOLUTE) STENT AMONG PATIENTS WITH STABLE CORONARY ARTERY DISEASE. DATA SOURCES: MEDLINE AND EMBASE FROM 1980 TO 2013 FOR RANDOMISED TRIALS COMPARING MEDICAL TREATMENT WITH REVASCULARISATION. MAIN OUTCOME MEASURE: ALL CAUSE MORTALITY. RESULTS: 100 TRIALS IN 93 553 PATIENTS WITH 262 090 PATIENT YEARS OF FOLLOW-UP WERE INCLUDED. CORONARY ARTERY BYPASS GRAFTING WAS ASSOCIATED WITH A SURVIVAL BENEFIT (RATE RATIO 0.80, 95% CREDIBILITY INTERVAL 0.70 TO 0.91) COMPARED WITH MEDICAL TREATMENT. NEW GENERATION DRUG ELUTING STENTS (EVEROLIMUS: 0.75, 0.59 TO 0.96; ZOTAROLIMUS (RESOLUTE): 0.65, 0.42 TO 1.00) BUT NOT BALLOON ANGIOPLASTY (0.85, 0.68TO 1.04), BARE METAL STENTS (0.92, 0.79 TO 1.05), OR EARLY GENERATION DRUG ELUTING STENTS (PACLITAXEL: 0.92, 0.75 TO 1.12; SIROLIMUS: 0.91, 0.75 TO 1.10; ZOTAROLIMUS (ENDEAVOR): 0.88, 0.69 TO 1.10) WERE ASSOCIATED WITH IMPROVED SURVIVAL COMPARED WITH MEDICAL TREATMENT. CORONARY ARTERY BYPASS GRAFTING REDUCED THE RISK OF MYOCARDIAL INFARCTION COMPARED WITH MEDICAL TREATMENT (0.79, 0.63 TO 0.99), AND EVEROLIMUS ELUTING STENTS SHOWED A TREND TOWARDS A REDUCED RISK OF MYOCARDIAL INFARCTION (0.75, 0.55 TO 1.01). THE RISK OF SUBSEQUENT REVASCULARISATION WAS NOTICEABLY REDUCED BY CORONARY ARTERY BYPASS GRAFTING (0.16, 0.13 TO 0.20) FOLLOWED BY NEW GENERATION DRUG ELUTING STENTS (ZOTAROLIMUS (RESOLUTE): 0.26, 0.17 TO 0.40; EVEROLIMUS: 0.27, 0.21 TO 0.35), EARLY GENERATION DRUG ELUTING STENTS (ZOTAROLIMUS (ENDEAVOR): 0.37, 0.28 TO 0.50; SIROLIMUS: 0.29, 0.24 TO 0.36; PACLITAXEL: 0.44, 0.35 TO 0.54), AND BARE METAL STE NTS (0.69, 0.59 TO 0.81) COMPARED WITH MEDICAL TREATMENT. CONCLUSION: AMONG PATIENTS WITH STABLE CORONARY ARTERY DISEASE, CORONARY ARTERY BYPASS GRAFTING REDUCES THE RISK OF DEATH, MYOCARDIAL INFARCTION, AND SUBSEQUENT REVASCULARISATION COMPARED WITH MEDICAL TREATMENT. ALL STENT BASED CORONARY REVASCULARISATION TECHNOLOGIES REDUCE THE NEED FOR REVASCULARISATION TO A VARIABLE DEGREE. OUR RESULTS PROVIDE EVIDENCE FOR IMPROVED SURVIVAL WITH NEW GENERATION DRUG ELUTING STENTS BUT NO OTHER PERCUTANEOUS REVASCULARISATION TECHNOLOGY COMPARED WITH MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629211 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Death