BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1822783 · Received August 26, 2010

    Report

    Report Number
    2953200-2010-01629
    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
    NIQ
    PMA / PMN Number
    P060033
    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). EVAL, 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 APPROX 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 MONTHS F/U'S, PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS. IT IS REPORTED THAT THE PT SUFFERED A NON-ST SEGMENT ELEVATION MI APPROX 11 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PT PRESENTED TO THE EMERGENCY DEPT WITH CRUSHING CHEST PAIN AND SHORTNESS OF BREATH. THE PT 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 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 PT TOLERATED THE PROCEDURE WELL. AT 12 MONTH F/U, PT'S CURRENT CARDIAC STATUS WAS UNSTABLE ANGINA. REFERENCE: MFR REPORT# 2953200-2010-01628, 01630, 01631.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention