BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2362934 · Received December 8, 2011

    Report

    Report Number
    9612164-2011-01625
    Event Type
    Injury
    Date Received
    December 8, 2011
    Date of Event
    October 15, 2011
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LIPID LOWERING DRUGS, CLOPIDOGREL AND ASA. (B)(4). EVALUATION RESULTS (B)(4) INHERENT RISK OF PROCEDURE (MYOCARDIAL INFARCTION) MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT DURING THE INDEX PROCEDURE BOTH (B)(6) STUDY STENTS WERE IMPLANTED TO THE LAD.

    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 AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE PROXIMAL RCA. THE FOLLOWING DAY THE PATIENT SUFFERED A MYOCARDIAL INFARCTION (MI). IT IS UNKNOWN WHETHER THE REPORTED MI WAS RELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE. REF MFR# 9612164-2011-01624, 9612164-2011-01625

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0002833292

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization BETA-BLOCKERS, ACE, CA++ ANTAGONIST