BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 1963271 · Received January 13, 2011

    Report

    Report Number
    2953200-2011-00093
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT OVER-THE-WIRE (OTW) DRUG-ELUTING STENT WAS IMPLANTED AT THE PROXIMAL LAD. IT IS REPORTED THAT A DISSECTION OCCURRED, WHICH REQUIRED THE PLACEMENT OF A SECOND ENDEAVOR SPRINT OTW STENT. INVESTIGATOR INDICATED A DEFINITE RELATIONSHIP TO THE STUDY DEVICE. IT IS REPORTED THAT PT RECOVERED WITH TREATMENT. A STAGED PROCEDURE OF THE MID LCX WAS CARRIED OUT 2 DAYS LATER. ONE ENDEAVOR SPRINT OTW DRUG-ELUTING STENT WAS IMPLANTED. A STAGED PROCEDURE OF THE 1ST OBTUSE MARGINAL WAS CARRIED OUT ON THE SAME DAY. ONE ENDEAVOR SPRINT OTW DRUG-ELUTING STENT WAS IMPLANTED. (MFR 2953200-2011-00094).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention