BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2041948 · Received March 30, 2011

    Report

    Report Number
    9612164-2011-00127
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT RX DRUG ELUTING STENT WAS IMPLANTED TO THE MID LCX DURING INDEX PROCEDURE. APPROXIMATELY 7 WEEKS POST INDEX PROCEDURE, PT WAS REPORTED TO HAVE SUFFERED A NON Q WAVE MI AND STENT THROMBOSIS. PT WAS ADMITTED TO HOSPITAL WITH CHEST PAIN AND 'POSITIVE TROPONIN, PEAKING AT 10.42'. A DIAGNOSTIC ANGIOGRAPHY SHOWED 99% INSTENT RESTENOSIS OF THE LAD. THIS WAS TREATED WITH A NON-MEDTRONIC STENT WHICH SANDWICHED A PREVIOUSLY PLACED STENT IN THE LAD. THE STENT IN THE LCX WAS SHOWN TO BE PATENT. PT RECOVERED WITH MEDICATION AND WAS DISCHARGED 3 DAYS LATER. THE INVESTIGATOR REPORTED THAT THE MI EVENT WAS NOT RELATED TO THE STUDY DEVICE AND WAS POSSIBLY RELATED TO THE STUDY PROCEDURE/ DRUG.

    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 80 YR Hospitalization| R