BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2023550 · Received March 16, 2011

    Report

    Report Number
    9612164-2011-00049
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    November 5, 2010
    Report Date
    February 14, 2011
    Manufacturer
    MEDTRONIC IRELAND
    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

    (B)(4). EVALUATION: RESULTS: (MI). CONCLUSIONS: NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    THE PT HAD AN ENDEAVOR SPRINT STENT IMPLANTED THE PROX LAD. THE DAY AFTER THE INDEX PROCEDURE, THE PT SUFFERED HYPERTENSION AND BRADYCARDIA AND RECOVERED WITHOUT TREATMENT. TWO DAYS AFTER INDEX PROCEDURE, THE PT SUFFERED FROM ANGINA AND RECOVERED WITHOUT TREATMENT. ONE MONTH AFTER THE INDEX PROCEDURE, THE PT SUFFERED FROM DULL BACK AND SHOULDER PAIN AND RECOVERED WITHOUT TREATMENT. A YEAR AND TWO MONTHS AFTER THE INDEX PROCEDURE, THE PT HAD AN ENDEAVOR SPRINT STENT IMPLANTED IN THE PROX RCA. ONE AND 6 MONTHS FROM THE INDEX PROCEDURE, THE PT HAD ANOTHER STENT IMPLANTED IN THE MID LAD. CEC COMMENTS: MI DURING THE INDEX PROCEDURE OR RE-PCI, NON Q-WAVE MI NOT IN THE TERRITORY OF THE TARGET VESSEL; SIDE BRANCH OCCLUSION, PERIPROCEDURAL MI DUE TO THE LOSS OF THE SIDE BRANCH DURING PCI TO LAD. (REF MFR REPORT NUMBER 9612164-2011-00050).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000520195

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization