BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2051086 · Received April 5, 2011

    Report

    Report Number
    9612164-2011-00161
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    May 10, 2012
    Report Date
    May 14, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: RESULTS: ST.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A REVASCULARIZATION OF THE LEFT POSTERIOR DESCENDING ARTERY AND MID LAD (BALLOON ONLY) WAS CARRIED OUT APPROXIMATELY 16 MONTHS POST THE INDEX PROCEDURE DUE TO CORONARY ARTERY RESTENOSIS. THE INVESTIGATOR HAS INDICATED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    PATIENT RECEIVED A 3.0MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE PROX RCA DURING INDEX PROCEDURE. TOTAL OCCLUSION FOR RCA WAS CONFIRMED DURING PROCEDURE AND REVASCULARIZATION WAS PERFORMED WITH DEPLOYMENT OF TWO ENDEAVOR SPRINT RX STENTS (DETAILS UNKNOWN) TO TARGET LESION. AS A SMALL AMOUNT OF THROMBUS WAS STILL PRESENT, THROMBECTOMY WAS ALSO PERFORMED. IT WAS REPORTED THAT THE PATIENT SUFFERED AN ACUTE NSTEMI ONE DAY POST INDEX PROCEDURE. IT WAS REPORTED THAT PATIENT UNDERWENT TO A STAGED PROCEDURE 3 DAYS POST INDEX PROCEDURE. A 2.5MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RX STENT WAS DEPLOYED TO PROX CS. IT WAS REPORTED THAT THE STAGED PROCEDURE WAS COMPLICATED BY THE CONFIRMATION OF A THROMBUS TO TARGET LESION. INVESTIGATOR HAS CONFIRMED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE AND TO THE ANTIPLATELET STUDY DRUG; HOWEVER, THERE WAS A DEFINITE POSSIBILITY THAT THE EVENT WAS RELATED TO THE PROCEDURE. NO OTHER CLINICAL SEQUELAE WERE REPORTED. (MFR #9612164-2011-00158, 9612164-2011-00159 & 9612164-2011-00160).

    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 60 YR Hospitalization DUAL ANTIPLATELET THERAPY