BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 2023306 · Received March 16, 2011

    Report

    Report Number
    9612164-2011-00077
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    March 26, 2009
    Report Date
    March 14, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT THROMBOSIS.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) STENT IMPLANTED TO THE MID LCX. A DISSECTION IS REPORTED TO HAVE OCCURRED DURING THE PROCEDURE WHICH REQUIRED THE PLACEMENT OF TWO ADDITIONAL ENDEAVOR SPRINT STENTS. APPROXIMATELY 3 WEEKS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A STAGED PROCEDURE OF THE PROXIMAL LAD. PATIENT HAD TWO ENDEAVOR SPRINT STENTS IMPLANTED. STENT THROMBOSIS OF THE MID LCX WAS CONFIRMED AT THE TIME OF THIS PROCEDURE. THE PATIENT HAD A DRIVER RX STENT IMPLANTED TO THE MID LCX DUE TO RESTENOSIS AFTER PREVIOUS PTCA ON THE SAME DATE. PATIENT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY FOLLOW-UP AND HAD CARDIAC STATUS OF STABLE ANGINA AT 6 MONTH FOLLOW-UP. APPROXIMATELY 6.5 MONTHS POST INDEX PROCEDURE STENT THROMBOSIS IS REPORTED TO HAVE OCCURRED. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS RELATED TO THE STUDY DEVICE. PATIENT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 1 YEAR, 1.5 YEAR, 2 YEAR AND 2.5 YEAR FOLLOW-UP. REF MFR REPORT NUMBERS 2953200200801239, 2953200200801240, 2953200200801241, 9612164201100075 AND 9612164201100076.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THERE WAS AN ENDEAVOR STENT IMPLANTED IN THE RAMUS BRANCH DURING A REVASCULARIZATION ON THE SAME DAY AS STENT THROMBOSIS EVENT APPROXIMATELY 6 MONTHS POST INDEX PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization ASPIRIN| CLOPIDOGREL| ASPIRIN| CLOPIDOGREL