BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1963261 · Received January 13, 2011

    Report

    Report Number
    2953200-2011-00092
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 10, 2010
    Report Date
    April 18, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT WAS IMPLANTED AT THE PROXIMAL LCX FOR TREATMENT OF THE TARGET LESION. IT IS REPORTED THAT A SECOND ENDEAVOR SPRINT RX STENT WAS IMPLANTED DUE TO A SMALL DISSECTION. INVESTIGATOR REPORTED A POSSIBLE RELATIONSHIP TO THE STUDY DEVICE. IT IS REPORTED THAT THE PT RECOVERED WITH TREATMENT.

    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 53 YR Required Intervention & CLOPIDOGREL AT TIME OF EVENT.| PT WAS TAKING ASPIRIN