BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3003567 · Received March 14, 2013

    Report

    Report Number
    9612164-2013-00282
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    February 28, 2013
    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

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

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, 1 ENDEAVOR SPRINT DRUG-ELUTING STENT WAS IMPLANTED IN THE 1ST OM. APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED AN MI IN THE TARGET VESSEL AND ALSO HAD A REVASCULARIZATION OF THE TARGET LESION DUE TO INSTENT RESTENOSIS 3 DAYS POST THE MI. ANOTHER BRAND OF DRUG-ELUTING STENT WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFUL. THE INVESTIGATOR HAS INDICATED THAT THE EVENTS WERE DEFINITELY RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107920 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001031152

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention