BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2230838 · Received August 26, 2011

    Report

    Report Number
    9612164-2011-01025
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 4, 2011
    Report Date
    February 25, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (STENT THROMBOSIS/ MYOCARDIAL INFARCTION/REVASC).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE MID CIRCUMFLEX AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE PROXIMAL LAD. APPROX FIVE WEEKS POST INDEX PROCEDURE THE PT WAS REHOSPITALIZED. AN ANGIOGRAM WAS PERFORMED AND STENT THROMBOSIS WAS CONFIRMED. THE FOLLOWING DAY RE-PTCA OF TARGET VESSEL WAS PERFORMED DUE TO THE THROMBOSIS (BALLOON AND BARE METAL STENT). THE INVESTIGATOR INDICATED THAT THE REPORTED EVENTS WERE PROBABLY RELATED TO THE STUDY DEVICE. ONE DAY LATER THE PT SUFFERED A MYOCARDIAL INFARCTION (MI). THE REPORTED MI WAS NOT RELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT REPORTED MI WAS UNRELATED TO THE STUDY STENT. (REF MFR # 9612164201101026).

    Description of Event or Problem · 1

    INVESTIGATOR INDICATED THAT THE REPORTED TVR AND STENT THROMBOSIS ARE DEFINITELY RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT A NON MDT STENT WAS IMPLANTED DURING THE PREVIOUSLY REPORTED REVASCULARIZATION OF TARGET VESSEL PERFORMED FIVE WEEKS POST INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001427326

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention LIPID LOWERING DRUGS| ASA| NITRATE| ACE| CLOPIDOGREL