BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 1062098 · Received June 18, 2008

    Report

    Report Number
    2953200-2008-00432
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 20, 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

    EVAL, RESULTS AND CONCLUSION: (LACK OF INFO).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE ENDEAVOR SPRINT STENT WAS IMPLANTED (3.0 X 15MM) TO TREAT THE PROXIMAL LEFT CIRCUMFLEX ARTERY. THE SAME DAY AS IMPLANT THE PT SUFFERED AN ACUTE NON-STEMI. THE INVESTIGATOR HAS INDICATED THAT THE LOCATION OF THE INFARCTION WAS POSTERIOR OF THE TARGET LESION. MODERATE CHEST PAIN AFTER INTERVENTION POSSIBLY DUE TO PERIPHERAL CORONARY EMBOLUS. NO ECG CHANGES DURING FIRST 5 HOURS NO ENZYME RISE PT AT THE TIME WITHOUT COMPLAINTS 12 HOURS LATER MODERATE ENZYME RISE. THE INVESTIGATOR ASSESSED THE EVENT AS A NON Q-WAVE MI & THAT THE EVENT WAS UNRELATED TO THE 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 NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000520199

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention