BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 1051784 · Received May 21, 2008

    Report

    Report Number
    2953200-2008-00337
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 21, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LACK OF INFORMATION.

    Description of Event or Problem · 1

    TWO LESIONS WERE TREATED, ONE STENT ENSP35018X WAS IMPLANTED IN THE MID LEFT CIRCUMFLEX AND ONE (REF MDR 2953200-2008-00338) STENT IN MID LAD. ON THE SAME DAY AS IMPLANT, THE PATIENT SUFFERED A HEMOPERICARDIAL BLEED. IT WAS REPORTED THAT THE PROVOCATION OF THE BLEEDING EVENT WAS PCI INSTRUMENTATION. THE BLEEDING EVENT LED TO THE PATIENT REQUIRING SURGERY. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT OR TO THE STUDY PROCEDURES. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES.

    Description of Event or Problem · 2

    TWO LESIONS WERE TREATED ONE STENT ENSP35018X WAS IMPLANTED WAS IMPLANTED IN THE MID LEFT CIRCUMFLEX AND ONE (REF MDR 2953200-2008-00338) STENT IN MID LAD. ON THE SAME DAY AS IMPLANT THE PATIENT SUFFERED A HEMOPERICARDIAL BLEED. IT WAS REPORTED THAT THE PROVOCATION OF THE BLEEDING EVENT WAS PCI INSTRUMENTATION. THE BLEEDING EVENT LED TO THE PATIENT REQUIRING SURGERY. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT OR TO THE STUDY PROCEDURES. 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 NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000563180

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CLOPIDOGREL/TICLOPIDINE 24 HRS BEFORE THE EVENT.| THE PT WAS TAKING ASA AND
    2 UNK Required Intervention