BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CYPHER JAPAN

    MDR report key: 7267464 · Received February 13, 2018

    Report

    Report Number
    9616099-2018-01860
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    August 31, 2017
    Report Date
    February 27, 2018
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION FUKU ET AL IMPACT OF DUAL ANTIPLATELET THERAPY BEYOND 1 YEAR ON CLINICAL OUTCOMES OF PATIENTS WITH STENT FRACTURE OR PERI-STENT CONTRAST STAINING AFTER SIROLIMUS-ELUTING STENT IMPLANTATION; CIRC J. 2017 DEC 25;82(1):211-217; REPORT 58 EVENTS OF SPONTANEOUS MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110657 UNKNOWN CYPHER JAPAN CORONARY DRUG-ELUTING STENT NIQ CORDIS CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R