BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 2231141 · Received August 26, 2011

    Report

    Report Number
    9612164-2011-01031
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 15, 2011
    Report Date
    June 16, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: BASED ON THE INFO PROVIDED NO ROOT CAUSE CAN BE DETERMINED. RESTENOSIS.

    Additional Manufacturer Narrative · 1

    PATIENT HAS A HISTORY OF DIABETES. INDEX PROCEDURE WAS PROMPTED BY OLD MI. APPROXIMATELY 15.5 MONTHS POST INDEX PROCEDURE THE PATIENT UNDERWENT REVASCULARIZATION OF THE RCA DUE TO RESTENOSIS. THE PATIENT WAS TREATED WITH AN ENDEAVOR RX STENT. INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Additional Manufacturer Narrative · 1

    PATIENT RECOVERED FROM THE PREVIOUSLY REPORTED REVASCULARIZATION OF THE RCA WHICH WAS CARRIED OUT APPROXIMATELY 15.5 MONTHS POST INDEX PROCEDURE

    Description of Event or Problem · 1

    A DRIVER CORONARY STENT SYSTEM AND A DRUG ELUTING STENT WERE DEPLOYED IN THE DISTAL RCA AND THE RIGHT PDA DURING INDEX PROCEDURE TO TREAT A RESTENOSED LESION WHICH HAD BEEN TREATED BEFORE. PROCEDURE RESULTED IN 0% STENOSIS. A F/U ANGIOGRAM APPROXIMATELY 8 MONTHS LATER REVEALED RESTENOSIS AT THE SITE OF STENT IMPLANT. POBA WAS PERFORMED. THE INVESTIGATOR REPORTS THAT THERE IS A CAUSAL RELATIONSHIP WITH THE PRODUCT, BUT THERE IS NO CAUSAL RELATIONSHIP WITH THE PROCEDURE/DRUG. PT IS REPORTED TO BE IN REMISSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER RX CORONARY STENT SYSTEM STENT, CORONARY MAF MEDTRONIC IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention CLOPIDOGREL