BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2230615 · Received August 11, 2011

    Report

    Report Number
    9612164-2011-00910
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 14, 2011
    Report Date
    February 25, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (MYOCARDIAL INFARCTION/REVASCULARIZATION).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE MID RCA, ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE DISTAL RCA AND ONE ENDEAVOR SPRINT RX DRUG- ELUTING STENT IMPLANTED TO THE SECOND OBTUSE MARGINAL. APPROXIMATELY 3.5 MONTHS POST INDEX PROCEDURE THE PATIENT WAS REHOSPITALIZED DUE TO A MI. THE MI WAS RELATED TO THE TARGET VESSEL. THE FOLLOWING DAY AN ANGIOGRAM WAS PERFORMED REASON FOR ANGIOGRAM RECURRENT ANGINA. RESTENOSIS OF TARGET LESION/VESSEL WAS SEEN. REPEAT PCI WAS PERFORMED (DES). THE PTCA WAS SUCCESSFUL. THE INVESTIGATOR INDICATED THAT THE REPORTED MI AND REVASCULARIZATION WERE RELATED TO THE STUDY STENT. (REF MFR # 9612164201100910 AND 9612164201100911).

    Description of Event or Problem · 1

    THE 3RD ENDEAVOR IMPLANTED DURING THE INDEX PROCEDURE WAS IMPLANTED IN THE CIRCUMFLEX ARTERY AND NOT THE 2ND OBTUSE MARGINAL AS PREVIOUSLY REPORTED. THE DES IMPLANTED DURING THE PREVIOUSLY REPORTED REVASCULARIZATION WAS IMPLANTED IN THE RCA. THE INVESTIGATOR INDICATED THAT THE REPORTED MI <(>&<)> REVASCULARIZATION WERE DEFINITELY RELATED TO THE STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0002269588

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention LIPID LOWERING DRUGS| IT IS REPORTED THAT THE PATIENT HAD STOPPED TAKING| AND ASA AT TIME OF REPORTED EVENT| ACE INHIBITOR| PATIENT WAS TAKING BETA-BLOCKERS| CLOPIDOGREL 3 WEEKS PRIOR TO THE REPORTED MI. THE