BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1970466 · Received January 20, 2011

    Report

    Report Number
    2953200-2011-00145
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    October 19, 2012
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: (MYOCARDIAL INFARCTION AND TVR), (THE PT SUFFERED FROM: STABLE ANGINA PECTORIS, NON-INSULIN-DEPENDENT DIABETES MELLITUS, HYPERTENSION, HYPERLIPIDEMIA AND IS AN EX-SMOKER). EVALUATION CODES, CONCLUSIONS: OTHER (PATIENT'S CONDITION PREDISPOSED EVENT).

    Description of Event or Problem · 1

    APPROXIMATELY 23 MONTHS POST INDEX PROCEDURE THE PATIENT HAD A TARGET VESSEL REVASCULARIZATION OF THE RCA USING A NON-MEDTRONIC STENT. IT WAS NOT ASSESSED IF THE EVENT WAS RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY IMPLANTED A 3.5MM DIAMETER X 30MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO THE DISTAL RIGHT. PRE-DILATATION TOOK PLACE USING A 3.5 X 15MM, WHICH RESULTED IN 0% STENOSIS. DURING THE PCI, A Q-WAVE MYOCARDIAL INFARCTION WAS OBSERVED AND TVR WAS PERFORMED. SEVERAL DAYS POST-PROCEDURE, THE PT WAS DISCHARGED FROM HOSPITAL AND THE 30 DAY FOLLOW-UP CONFIRMED NO AE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    DURING THE PCI, A Q-WAVE MYOCARDIAL INFARCTION RELATED TO THE PROCEDURE WAS OBSERVED. REVASCULARIZATION WAS PERFORMED AT MID RCA USING A (3.50 X 30MM) DRIVER RX STENT TO TREAT A DISSECTION RELATED TO THE PROCEDURE. APPROXIMATELY 10 MONTHS POST PCI, MI WAS CONFIRMED IN DISTAL RCA, TREATED BY REVASCULARIZATION. APPROXIMATELY 11 MONTHS POST PCI REVASCULARIZATION WAS SUCCESSFULLY PERFORMED AT MID AND DISTAL RCA. A 12 MONTH FOLLOW-UP CONFIRMED NO AE. REF 9612164-2012-00053.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening ASPIRIN| CLOPIDOGREL