BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 1822782 · Received August 26, 2010

    Report

    Report Number
    2953200-2010-01631
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 27, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: (MYOCARDIAL INFARCTION).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENTS WERE IMPLANTED, ONE IN THE MID LAD AND ONE IN THE PROXIMAL LAD. A STAGED PROCEDURE WAS CARRIED OUT APPROXIMATELY 2 WEEKS LATER. THERE WAS AN ENDEAVOR SPRINT OVER THE WIRE (OTW) DRUG-ELUTING STENT WAS IMPLANTED IN THE DISTAL RCA AND A DRIVER RAPID EXCHANGE (RX) STENT IMPLANTED IN THE MID-RCA. AT 30 DAY AND 6 MONTH FOLLOW-UP'S, PATIENT WAS ASYMPTOMATIC/FREE OF SYMPTOMS. IT IS REPORTED THAT THE PATIENT SUFFERED A NON-ST SEGMENT ELEVATION MI APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CRUSHING CHEST PAIN AND SHORTNESS OF BREATH. THE PATIENT TOOK ASPIRIN WITHOUT RELIEF. AT THAT TIME, HIS CARDIAC ENZYMES WERE ELEVATED. A HEART CATHETERIZATION WAS DONE WHICH REVEALED A 95% LESION OF THE RAMUS WITH 70-80% DISTAL LAD AND 50% RCA. HIS PREVIOUS STENTS IN HIS RCA AND LEFT CORONARY WERE STILL PATENT. HIS EJECTION FRACTION WAS 50%. SUBSEQUENTLY, HE UNDERWENT CORONARY ARTERY BYPASS GRAFT X2 WITH A LIMA TO THE LAD AND SAPHENOUS VEIN GRAFT TO THE RAMUS. IT IS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL. AT 12 MONTH FOLLOW-UP, PATIENT'S CURRENT CARDIAC STATUS WAS UNSTABLE ANGINA. REFERENCE: MFR REPORT# 2953200-2010-01628, 2953200-2010-01629, 2953200-2010-01630.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention