BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2880803 · Received December 20, 2012

    Report

    Report Number
    9612164-2012-01806
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 5, 2012
    Report Date
    January 31, 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 (DEATH). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED MI EVENT OF 15 MONTHS POST INDEX PROCEDURE ACTUALLY OCCURRED 9 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT SUFFERED A SECOND MI EVENT APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE THE PATIENT UNDERWENT CABG SURGERY OF THE LAD AND THE LCX. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD AN ENDEAVOR SPRINT DRUG-ELUTING STENT IMPLANTED IN THE LAD. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A TARGET VESSEL REVASCULARIZATION AND HAD A STENT IMPLANTED IN THE TARGET LESION. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE. THE PATIENT WAS RE-HOSPITALIZED APPROXIMATELY 15 MONTHS POST THE INDEX PROCEDURE DUE TO AN MI (NON TARGET VESSEL). THE INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE PATIENT ALSO HAD A NON TVR TWO DAYS POST THE MI (NON TARGET VESSEL) EVENT AND AN ENDEAVOR DRUG ELUTING STENT WAS IMPLANTED IN THE OM1. THE INVESTIGATOR HAS INDICATED THAT THE TVR WAS UNRELATED TO THE STUDY DEVICE. PATIENT DEATH OCCURRED APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE. CAUSE OF DEATH WAS CARDIOGENIC SHOCK AND HEART FAILURE. IT IS REPORTED THAT THE PATIENT HAD RESTENOSIS OF THE STENTS IN THE ACX , CARDIAC SURGERY WAS PERFORMED AND THE PATIENT DIED. INVESTIGATOR INDICATED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Death| H| R ASPIRIN, CLOPIDOGREL