BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 3951088 · Received July 22, 2014

    Report

    Report Number
    2134265-2014-04326
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT THROMBOSIS, CHEST PAIN, DIAPHORESIS, NAUSEA AND HYPOTENSION OCCURRED. THE PATIENT PRESENTED WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THE 85% STENOSED TARGET LESION WAS LOCATED IN THE OSTIAL OF THE NON TORTUOUS AND MILDLY CALCIFIED PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.00X20MM PROMUS PREMIER¿ STENT WAS SELECTED TO TREAT THE TARGET LESION. THE DEVICE WAS DEPLOYED AND WAS WELL APPOSED IN THE TARGET LESION. PATIENT WAS GIVEN ANGIOMAX VIA IV. APPROXIMATELY 45 MINUTES AFTER STENT DEPLOYMENT, THE PATIENT EXPERIENCED CHEST PAIN, DIAPHORESIS, NAUSEA AND HYPOTENSION. ONE DAY POST PROCEDURE, REPEAT LEFT HEART CATHETERIZATION WAS RECOMMENDED. PATIENT UNDERWENT THE SAME PROCEDURE AND WAS GIVEN REOPRO. SUBSEQUENTLY, CORONARY ANGIOGRAPHY REVEALED THAT THE PROXIMAL STENT WAS PATENT BUT IN THE MIDDLE OF THE STENT THERE WAS A FILLING DEFECT CONSISTENT WITH A THROMBUS AND WAS NON OCCLUSIVE. THE LESION WAS DILATED USING A 3.5MMX12MM EMERGE BALLOON CATHETER. A 3.0MM X 32MM PROMUS PREMIER STENT WAS DEPLOYED IN THE DISTAL PORTION AND A 3.5MMX16MM PROMUS PREMIER STENT WAS DEPLOYED IN THE PROXIMAL PORTION IN AN OVERLAPPING FASHION COVERING THE PREVIOUSLY IMPLANTED 3.00X20MM PROMUS PREMIER STENT. ASPIRATION THROMBECTOMY WAS PERFORMED AND REVEALED NEGATIVE PRESENCE OF THROMBUS. ACTIVATED CLOTTING TIME (ACT) WAS MEASURED AND FOUND TO BE 120. POST PROCEDURE, THE PATIENT WAS GIVEN 325MG ASPIRIN AND 60MG PRASUGREL. ANGIOGRAM SHOWED EXCELLENT RESULTS IN THE LEFT CORONARY ARTERY. FLOW IN THE LAD WAS NORMAL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427931 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952820300 0016846059

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention