BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3883101 · Received June 19, 2014

    Report

    Report Number
    9612164-2014-00651
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    January 1, 2011
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, TWO ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED IN THE LAD. GREATER THAN 6 WEEKS POST THE INDEX PROCEDURE, THE PATIENT SUFFERED A MYOCARDIAL INFARCTION. APPROXIMATELY 9 MONTHS POST THE INDEX PROCEDURE, A REVASCULARIZATION OF THE LCX AND LAD WAS CARRIED OUT DUE TO IN STENT RESTENOSIS. INVESTIGATOR HAS INDICATED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE OUTCOME IS REPORTED AS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360023 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0004336163

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention