BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2982014 · Received February 28, 2013

    Report

    Report Number
    9612164-2013-00217
    Event Type
    Death
    Date Received
    February 28, 2013
    Date of Event
    December 21, 2010
    Report Date
    January 29, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DEATH, STENT THROMBOSIS, MYOCARDIAL INFARCTION AND RESTENOSIS OF THE STENTED ARTERY. DEATH, STENT THROMBOSIS, MYOCARDIAL INFARCTION AND RESTENOSIS OF THE STENTED ARTERY. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. UNABLE TO CONFIRM COMPLAINT. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW THE INFORMATION COULD NOT BE MATCHED WITH OTHER INFORMATION KNOWN TO MEDTRONIC. ATTEMPTS MADE TO OBTAIN ADDITIONAL DETAILS. AGE AT EVENT - MEAN AGE. DATE OF EVENT - DATE OF PUBLICATION. DATE OF DEATH - DATE OF PUBLICATION. CIRC CARDIOVASC INTERV IS AVAILABLE AT HTTP://CIRCINTERVENTIONS.AHAJOURNALS.ORG REFERENCE - DOI: 10.1161/CIRCINTERVENTIONS.110.959924 "NOVEL APPROACHES FOR PREVENTING OR LIMITING EVENTS IN DIABETIC PATIENTS (NAPLES-DIABETES) TRIAL."

    Description of Event or Problem · 1

    THIS STUDY COMPARED THREE (3) DRUG-ELUTING STENTS IN DIABETIC PATIENTS IN ORDER TO EXPAND THE PAUCITY OF DATA ON THE EFFICACY OF VARIOUS DRUG-ELUTING STENTS IN DIABETIC PATIENTS. PATIENTS WERE RANDOMLY ASSIGNED TO SIROLIMUS-ELUTING STENTS (NON-MEDTRONIC), PACLITAXEL-ELUTING STENTS (NON-MEDTRONIC) AND EVEROLIMU S-ELUTING STENTS (ENDEAVOR SPRINT RX GROUP). THE PRIMARY END POINT WAS THE 3-YEAR COMPOSITE OF MAJOR ADVERSE CARDIAC EVENTS (MACE), INCLUDING DEATH OF ANY CAUSE, MYOCARDIAL INFARCTION, AND CLINICALLY DRIVEN TARGET VESSEL REVASCULARIZATION. PERI-PROCEDURAL MYOCARDIAL INFARCTION OCCURRED IN 10 PATIENTS OF THE SIROLIMUS-ELUTING STENT GROUP, IN 10 PATIENTS OF THE PACLITAXEL-ELUTING STENT GROUP, AND IN 13 PATIENTS OF THE ENDEAVOR SPRINT STENT GROUP. THE POST HOC COMPARISONS SHOWED NO SIGNIFICANT DIFFERENCE BETWEEN SIROLIMUS-ELUTING VERSUS PACLITAXEL-ELUTING GROUPS BUT A HIGHER MACE RATE IN THE ENDEAVOR SPRINT GROUP VERSUS BOTH THE SIROLIMUS-ELUTING GROUP AND THE PACLITAXEL-ELUTING GROUP. THE HIGHER MACE RATE IN THE ENDEAVOR SPRINT GROUP WAS MOSTLY DRIVEN BY A HIGHER RATE OF TARGET LESION REVASCULARIZATION. THE HIGHER MACE RATE IN THE ENDEAVOR SPRINT GROUP WAS OBSERVED AFTER THE FIRST YEAR FROM INTERVENTION. STENT THROMBOSIS OCCURRED GLOBALLY IN 4 PATIENTS: 1 PATIENT IN THE SIROLIMUS-ELUTING GROUP AND 3 PATIENTS IN THE ENDEAVOR SPRINT GROUP. TWO WERE DEFINITE AND 2 WERE PROBABLE. TWO PATIENTS IN THE ENDEAVOR SPRINT GROUP HAD SUBACUTE STENT THROMBOSIS CAUSING ACUTE MYOCARDIAL INFARCTION AND EVENTUAL DEATH. LATE STENT THROMBOSIS OCCURRED IN 1 PATIENT IN THE SIROLIMUS-ELUTING GROUP AND 1 PATIENT IN THE ENDEAVOR SPRINT GROUP. THE STUDY CONCLUSION SUGGESTED THAT IN DIABETIC PATIENTS, THE ENDEAVOR SPRINT STENT IS ASSOCIATED WITH A HIGHER 3-YEAR MACE RATE WHEN COMPARED WITH SIROLIMUS-ELUTING AND PACLITAXEL-ELUTING STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88441 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Death ASPIRIN, CLOPIDOGREL