BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRING RX

    MDR report key: 1062099 · Received June 18, 2008

    Report

    Report Number
    2953200-2008-00434
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 28, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, RESULTS: (MYOCARDIAL INFARCTION). (LACK OF INFO). RELATED TO ANOTHER DEVICE (PCI INSTRUMENTATION) EVAL, CONCLUSION: ANOTHER DEVICE CAUSED FAILURE (PCI INSTRUMENTATION). OTHER (LACK OF INFO) (SECONDARY INTERVENTION) (BLEED).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS TO BE SUFFERING FROM STABLE ANGINA AT THE TIME OF STENT PROCEDURE. ONE ENDEAVOR SPRING STENT WAS IMPLANTED TO THE MID LAD (2.5 X 24MM). THE PT SUFFERED BLEEDING DUE TO A PERFORATION OF THE CORONARY ARTERY. THE INVESTIGATOR HAS INDICATED THAT THE BLEEDING WAS CAUSED BY THE PCI INSTRUMENTATION. THE INVESTIGATOR REPORTED THAT THE EVENT WAS NOT RELATED TO THE STENT. ON THE DAY OF STENT IMPLANT THE PT SUFFERED AN ACUTE NON-STEMI. THE INVESTIGATOR HAS REPORTED THE CAUSE OF THE NON QWAVE MI WAS AN OCCLUDED DIAGONAL BRANCH AS A COMPLICATION OF THE PCI PROCEDURE. ECG WAS PERFORMED THE SAME DAY. 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 SPRING RX NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000554615

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention THE PT WAS TAKING ASA| TICLOPIDINE 24 HOURS BEFORE THE EVENT.| CLOPIDOGREL