BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 2092649 · Received May 10, 2011

    Report

    Report Number
    9612164-2011-00382
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    October 4, 2010
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF THE PROCEDURE (MI). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): RESULTS: (STENT THROMBOSIS, REVASCULARIZATION).

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT OTW DRUG ELUTING STENT DIAMETER 2.5MM LENGTH 14MM WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL ARTERY DURING INDEX PROCEDURE. IT IS REPORTED THAT ONE STENT WAS ATTEMPTED BUT NOT IMPLANTED DUE TO A FAILURE TO CROSS THE TARGET LESION. THIS STENT WAS RETRIEVED SUCCESSFULLY. INSTENT CORONARY ARTERY RESTENOSIS OF MODERATE INTENSITY WAS REPORTED APPROXIMATELY 3 WEEKS POST INDEX PROCEDURE. STENT THROMBOSIS WAS REPORTED TO HAVE OCCURRED. THE PATIENT EXPERIENCED CHEST PAIN WITH EXERTION. RANEXA DID NOT RELIEVE THE PAIN. PATIENT WAS ADMITTED AS AN OUTPATIENT FOR LEFT HEART CATHETERIZATION AND HAD ROTABLATOR AND STENT OF THE LEFT MAIN AND DIAGONAL ARTERIES. PATIENT ALSO UNDERWENT BALLOON-ONLY REVASCULARIZATION OF THE DISTAL RCA ON THE SAME DAY. THE INVESTIGATOR REPORTS THAT THE EVENT HAD NO RELATION TO THE STUDY DEVICE/PROCEDURE/DRUG. PATIENT IS REPORTED TO HAVE RECOVERED WITH TREATMENT.

    Description of Event or Problem · 1

    A NON-MEDTRONIC STENT WAS IMPLANTED IN THE 1ST DIAGONAL DURING THE PREVIOUSLY REPORTED REVASCULARIZATION.

    Description of Event or Problem · 1

    CLINICAL EVENTS COMMITTEE (CEC) DEEMED THAT A MI OCCURRED ON THE SAME DAY AS THE INDEX PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R ASPIRIN| CLOPIDOGREL