BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2010969 · Received March 4, 2011

    Report

    Report Number
    9612164-2011-00011
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    January 22, 2010
    Report Date
    February 9, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE PROXIMAL LAD DURING THE INDEX PROCEDURE. PT ASYMPTOMATIC/FREE OF SYMPTOMS AT 30 DAY AND 6 MONTH F/U. APPROX 7 MONTHS POST INDEX PROCEDURE, A BALLOON REVASCULARIZATION OF THE PROXIMAL LAD WAS PERFORMED. INDICATION FOR REVASCULARIZATION WAS POSITIVE HISTORY OR RECURRENT ANGINA PECTORIS PRESUMABLY RELATED TO TARGET VESSEL. INVESTIGATOR REPORTS INSTENT RESTENOSIS. INVESTIGATOR STATES THAT EVENT WAS RELATED TO STUDY STENT BUT NOT RELATED TO STUDY PROCEDURES. PT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 1 YEAR AND 1.5 YEAR F/U. APPROX 19 MONTHS POST INDEX PROCEDURE, PT UNDERWENT A NON-TARGET VESSEL REVASCULARIZATION. PT HAD ONE ENDEAVOR SPRINT RX STENT IMPLANTED TO THE MID RCA AND ONE ENDEAVOR SPRINT STENT IMPLANTED TO THE PLSA. THE PT IS REPORTED TO HAVE SUFFERED A POSTERIOR MI ON THE SAME DATE. INVESTIGATOR ASSESSED THAT THERE WAS NO RELATIONSHIP BETWEEN THE EVENT AND THE STUDY STENT. APPROX 22 MONTHS POST INDEX PROCEDURE, INVESTIGATOR REPORTS A REVASCULARIZATION OF THE MID LAD WAS PERFORMED. PT HAD ONE ENDEAVOR SPRINT STENT IMPLANTED. INDICATION FOR REVASCULARIZATION WAS POSITIVE HISTORY OR RECURRENT ANGINA PECTORIS PRESUMABLY RELATED TO TARGET VESSEL. INVESTIGATOR INDICATED THAT EVENT WAS NOT RELATED TO THE STUDY STENT. PT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 2.5 YEAR F/U. (REF MFR #9612164-2011-00012 & 9612164-2011-00013).

    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 58 YR Hospitalization ASPIRIN