BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2040875 · Received March 24, 2011

    Report

    Report Number
    9612164-2011-00111
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 2, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: MI. EVALUATION CONCLUSION: NO CONCLUSION CAN BE DRAWN. BASED ON THE INFO PROVIDED NO ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    PT HAD TWO STENTS IMPLANTED TO THE R-PDA; ONE ENDEAVOR SPRINT RX AND ONE ENDEAVOR SPRINT OTW. 'NO REFLOW' WAS REPORTED ON SAME DAY AS IMPLANT. PT WAS GIVEN MEDICATION AND RECOVERED WITH TREATMENT. PT SUFFERED AN ACUTE NON-STEMI LATERAL MI APPROX 6 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PT HAD 3 DAYS OF CHEST PAIN AND WAS ADMITTED TO THE HOSP FOR NON-ST ELEVATION. REVASCULARIZATION WAS PERFORMED AND A STENT WAS PLACED IN SAPHENOUS VEIN GRAFT TO THE SECOND DIAGONAL BRANCH. ALL OTHER PREVIOUS STENTS WERE PATENT. THE INVESTIGATOR REPORTS THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT/ PROCEDURE/ DRUG. PT RECOVERED WITH TREATMENT. (REF MFR #9612164-2011-00112).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R PATIENT ON ASPIRIN| AND CLOPIDOGREL AT TIME OF EVENT