BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1071346 · Received July 8, 2008

    Report

    Report Number
    2953200-2008-00520
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 9, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LACK OF INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE MID RCA. WHILE TRYING TO PROGRESS GUIDE CATHETER, THERE WAS A DISSECTION OF RCA. FIVE ENDEAVOR SPRINT RX STENTS WERE IMPLANTED AND WERE OVERLAPPING (MFR REPORT# 2953200-2008-00519 - 00523). ONE FURTHER STENT (BRAND NAME UNKNOWN) WAS ATTEMPTED TO BE IMPLANTED BUT FAILED TO REACH THE TARGET LESION. ON THE SAME DAY AS IMPLANT, THE PATIENT SUFFERED AN ACUTE NON-STEMI. THE INVESTIGATOR ASSESSED THE EVENT AS A NON Q-WAVE MI & THAT IT WAS NON DETERMINABLE AS TO WHETHER THE EVENT WAS RELATED TO THE STUDY STENT. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES.

    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 UNK Required Intervention