BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2172690 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00777
    Event Type
    Death
    Date Received
    July 20, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (DEATH).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PT HAD A 3.0 MM DIAMETER X 24 MM LENGTH DRUG-ELUTING STUDY STENT IMPLANTED TO THE DISTAL RCA. APPROXIMATELY 17 MONTHS POST INDEX PROCEDURE, THE PT UNDERWENT A NON-TARGET VESSEL REVASCULARIZATION. PT HAD A 3.0 MM X 9 MM ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE LMCA AND A 2.5 MM X 12 MM ENDEAVOR SPRINT RX STENT IMPLANTED TO THE PROXIMAL LAD. APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE, THE PT UNDERWENT A TARGET VESSEL REVASCULARIZATION. PT HAD ONE OTHER BRAND STENT IMPLANTED TO THE RPDA. THE TARGET STUDY DISTAL RCA STENT WAS PATENT. PT DEATH IS REPORTED TO HAVE OCCURRED (DATE OF PT'S DEATH IS UNK). NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. (REF MFR # 9612164-2011-00778).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0003676640

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death ASPIRIN| CLOPIDOGREL