BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1923679 · Received December 9, 2010

    Report

    Report Number
    2953200-2010-02483
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    October 22, 2010
    Report Date
    January 5, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (MYOCARDIAL INFARCTION AND THROMBOSIS).

    Description of Event or Problem · 1

    THE PT PRESENTED WITH CHEST PAIN AND WAS FOUND TO HAVE AN ACUTE MYOCARDIAL INFARCTION. SHE WENT TO THE CARDIAC CATHETERIZATION LAB ON THE SAME DAY AND WAS FOUND TO HAVE COMPLEX SINGLE VESSEL CORONARY ARTERY DISEASE IN THE LEFT ANTERIOR DESCENDING ARTERY. BALLOON ANGIOPLASTY IN THE DIAGONAL WAS PERFORMED. AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED IN THE DISTAL LAD. THERE APPEARED TO BE A DISTAL EDGE DISSECTION AND THIS WAS TREATED WITH A SECOND ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT. A THIRD ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD. THERE ALSO APPEARED TO BE A SMALL DYE STAIN IN THE ATYPICAL PORTION OF THE MYOCARDIUM, THIS IS LIKELY RELATED TO A TINY WIRE PERFORATION. THIS WAS WATCHED AND DEFINITELY SEALED OFF. SHE WAS SENT HOME ON ASPIRIN AND PLAVIX AND HER COUMADIN WAS DISCONTINUED. SHE WAS READMITTED APPROX 4 DAYS LATER AFTER SHE WAS FOUND TO HAVE A ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. SHE HAD A REPEAT CARDIAC CATHETERIZATION WHICH REVEALED ACUTE OCCLUSION OF THE ENTIRE LEFT ANTERIOR DESCENDING ARTERY SECONDARY TO THROMBOSIS MOST LIKELY RELATED TO EDGE DISSECTION TO THE PREVIOUSLY PLACED STENTS. SHE WAS ALSO FOUND TO HAVE A TOTALLY OCCLUDED DIAGONAL. PT UNDERWENT RECANALIZATION OF THE WHOLE LEFT ANTERIOR DESCENDING ARTERY USING BALLOON ANGIOPLASTY, THROMBECTOMY AND A DRUG-ELUTING STENT. SHE WAS PLACED ON INTEGRELIN AND PLAVIX AS WELL AS ASPIRIN. THE PT CURRENTLY STILL HAS COMPLAINTS OF SHORTNESS OF BREATH, BUT DOES NOT HAVE ANY CHEST PAIN. (REF MFR 2953200-2010-02482 AND 2953200-2010-02484).

    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 77 YR Female Required Intervention