BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 3014209 · Received March 21, 2013

    Report

    Report Number
    9612164-2013-00322
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    January 31, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PREVIOUSLY REPORTED TARGET VESSEL REVASCULARIZATION OCCURRED 57 MONTHS POST INDEX PROCEDURE AND NOT 45 MONTHS AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE 3 ENDEAVOR SPRINT DRUG-ELUTING STENTS WERE IMPLANTED, 2 IN THE LCX AND 1 IN THE LEFT MAIN. THE PATIENT SUFFERED AN ARC DEFINED MI THE SAME DAY AS STENT IMPLANTATION. IT IS REPORTED THAT APPROXIMATELY 45 MONTHS POST INDEX PROCEDURE, THE PATIENT HAD A TARGET VESSEL REVASCULARIZATION OF THE CX. IT IS NOT ASSESSED IF THE EVENT WAS RELATED TO THE DEVICE. APPROXIMATELY 59 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED AN MI. IT WAS NOT ASSESSED IF THE EVENT WAS RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117557 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000336671

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention CLOPIDOGREL AND ASPIRIN.