BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER SPRINT RX

    MDR report key: 7217928 · Received January 25, 2018

    Report

    Report Number
    9612164-2018-00147
    Event Type
    Injury
    Date Received
    January 25, 2018
    Date of Event
    March 11, 2015
    Report Date
    January 25, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL NAME: HEART VESSELS TITLE OF ARTICLE: SHORT- AND LONG-TERM BENEFITS OF DRUG-ELUTING STENTS COMPARED TO BARE METAL STENTS EVEN IN TREATMENT FOR LARGE CORONARY ARTERIES AUTHORS: LITERATURE REFERENCE: DOI 10.1007/S00380-015-0655-3 RECEIVED: 25 JULY 2014 ACCEPTED: 27 FEBRUARY 2015 PUBLISHED ONLINE: 11 MARCH 2015 YEAR: 2016 ISSUE#: 31. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CONSECUTIVE 228 PATIENTS UNDERWENT PCI WITH LARGE-SIZE STENTS FROM JAN 2004 TO DEC 2007 WERE ENROLLED IN THIS STUDY, OF THIS, 113 PATIENTS RECEIVED THE IMPLANTATION OF THE BARE METAL STENTS OF WHICH 31% WERE IMPLANTED WITH THE DRIVER BARE METAL STENTS. AT 8-MONTHS FOLLOW-UP, PATIENTS IN THE BMS GROUP UNDERWENT REVASCULARIZATION OF THE TARGET LESION AND TWO PATIENTS SUFFERED FROM VERY LATE STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61653 DRIVER SPRINT RX STENT, CORONARY MAF MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention