BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIROYAL ELITE PREMOUNTED STENT SYSTEM

    MDR report key: 2863091 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-08101
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P980001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EVENT DATE: (B)(6) 2003. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME PATIENT AS MDR ID# 2134265-2012-07486, 2134265-2012-07454. IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS, ANGINA, SPASM, AND MYOCARDIAL INFARCTION OCCURRED. IN (B)(6) 2002 THE PATIENT WAS TREATED WITH A NIR STENT IN THE OSTIAL RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2003, IN-STENT RESTENOSIS OF A NON-BSC STENT WAS PRESENT IN THE LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WAS TREATED WITH CUTTING BALLOON TECHNIQUE. IN ADDITION, THE IN-STENT RESTENOSIS OF THE PREVIOUSLY DEPLOYED NIR STENT IN OSTIAL RCA WAS TREATED WITH THE PLACEMENT OF A 3.50 X 13 MM NON-BSC STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIROYAL ELITE PREMOUNTED STENT SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE UNK274

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R