BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 2080564 · Received April 22, 2011

    Report

    Report Number
    9612164-2011-00274
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    September 8, 2008
    Report Date
    March 26, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: (MI). NO CONCLUSION CAN BE DRAWN (BASED ON THE INFO PROVIDED NO ROOT CAUSE CAN BE DETERMINED).

    Description of Event or Problem · 1

    A MICRO DRIVER RX STENT DIAMETER 2.5MM LENGTH 8MM WAS IMPLANTED IN THE PROXIMAL LAD DURING INDEX PROCEDURE OVERLAPPING A PREVIOUSLY IMPLANTED NON-MEDTRONIC STENT SUBSEQUENT TO A DISSECTION. APPROX 3 MONTHS POST INDEX PROCEDURE THE PT SUFFERED A NON-Q-WAVE MI. IT WAS REPORTED THAT THE PT HAD STABLE ANGINA SINCE THE INDEX PROCEDURE AND WAS READMITTED TO HOSPITAL APPROX 3 MONTHS POST STENT IMPLANT WITH UNSTABLE ANGINA AND A SUBSEQUENT RISE OF MARKERS. AN ANGIOGRAPHY REVEALED SEVERE LEFT MAIN STENOSIS. TWO DAYS LATER, THE PT UNDERWENT REVASCULARIZATION OF THE LMCA WITH PLACEMENT OF TWO NON-MEDTRONIC STENTS. THE INVESTIGATOR REPORTS THAT THE EVENT HAD NO RELATION TO THE STUDY DEVICE /PROCEDURE AND WAS NOT LIFE THREATENING. PT HAD STABLE ANGINA AT 6 MONTH F/U AND WAS ASYMPTOMATIC AT 1, 1.5, 2 AND 2.5 YR FOLLOW UPS. NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA 0000568974

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R 24 HRS PRIOR TO EVENT.| ASPIRIN| CLOPIDOGREL