BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2080523 · Received April 22, 2011

    Report

    Report Number
    9612164-2011-00281
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    October 27, 2009
    Report Date
    March 26, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: MI.

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE DISTAL RCA DURING INDEX PROCEDURE. PATIENT'S CARDIAC STATUS AT 30 DAY F/U WAS STABLE ANGINA. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 6 MONTH AND 11 MONTH F/U'S. IT IS REPORTED THAT THE PT SUFFERED AN ACUTE NON STEMI APPROX 12 MONTHS POST INDEX PROCEDURE. THE PT WAS ADMITTED TO HOSPITAL WITH COMPLAINTS OF CHEST PAIN AND EPIGASTRIC PAIN. IT IS REPORTED THAT THERE WERE ISCHEMIC CHANGES NOTED ON ECG WITH RAISED TROPONIN AND THERE WAS AN ANGIOGRAM PERFORMED. IT IS REPORTED THAT THE PT SUFFERED A Q-WAVE MI, LOCATED IN THE ANTERIOR, LATERAL NOT INVOLVING THE TARGET LESION. PATIENT WAS TAKING CLOPIDOGREL BUT NOT TAKING ASPIRIN AT THE TIME OF THE EVENT. IT IS REPORTED THAT THERE WAS A BALLOON ONLY REVASCULARIZATION OF THE SVG1 CARRIED OUT APPROX 16 MONTHS POST INDEX PROCEDURE TO TREAT RESTENOSIS AFTER PREVIOUS PTCA. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 18 MONTH AND 24 MONTH F/U'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000535653

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization CLOPIDOGREL