BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3855218 · Received June 9, 2014

    Report

    Report Number
    9612164-2014-00577
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    October 13, 2013
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (MI). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (MYOCARDIAL INFARCTION). (B)(4).

    Description of Event or Problem · 1

    APPROXIMATELY 54 MONTHS POST INDEX PROCEDURE A NON MEDTRONIC STENT WAS IMPLANTED IN THE 1ST OM DUE TO ANGINA. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. PATIENT RECOVERED.

    Description of Event or Problem · 1

    PREVIOUSLY REPORTED MI HAS BEEN ASSESSED AS PROBABLY RELATED TO THE STUDY DEVICE BY THE INVESTIGATOR.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD FOUR ENDEAVOR SPRINT DRUG-ELUTING STENTS IMPLANTED; TWO IN THE LAD AND TWO IN THE CX. APPROXIMATELY 51 MONTHS POST THE INDEX PROCEDURE, THE PATIENT HAD AN MI. PATIENT WAS HOSPITALIZED AND TREATED WITH MEDICATION. INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE. PATIENT IS CONTINUING WITH TREATMENT. APPROXIMATELY 54 MONTHS POST THE INDEX PROCEDURE THE PATIENT UNDERWENT A PCI OF THE LAD DUE TO IN-STENT RESTENOSIS. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE. PATIENT RECOVERED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335182 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization