BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1872842 · Received October 14, 2010

    Report

    Report Number
    2024168-2010-02149
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND THROMBOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE THREE OTHER PROMUS STENTS, 3.5 X 15 (PART 1009542-15B, LOT 0012241), 3.0 X 12 (PART 1009541-12B, LOT 0011342), AND 3.5 X 12 (PART 1009542-12B, LOT 9120142), INDICATED ARE EACH BEING FILED UNDER SEPARATE MFR#'S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PROMUS STENTS WERE IMPLANTED ON (B)(6) 2010, IN THE MID AND PROXIMAL LEFT ASCENDING DIAGONAL (LAD). THE PROCEDURE WAS CONSIDERED, SUCCESSFUL. IN THE EVENING OF (B)(6) 2010, THE PT COMPLAINED OF CHEST PAIN AND WAS RETURNED TO THE CATH LAB. IT WAS NOTED THAT THE LAD WAS TOTALLY OCCLUDED AND THROMBOSED. A GUIDE WIRE, BALLOON CATHETER AND A NON-ABBOTT THROMBUSTER WERE USED TO REMOVE THE CLOT AND AN ADDITIONAL TWO PROMUS STENTS WERE PLACED DISTALLY AND PROXIMALLY TO THE PREVIOUSLY DEPLOYED PROMUS STENTS. POST DILATATION WAS PERFORMED ON THE ENTIRE STENTED REGION; HOWEVER, THE ENTIRE AREA HAD CLOTTED OFF AGAIN. POST DILATATION WAS AGAIN PERFORMED ON THE STENTED SEGMENTS AND FLOW WAS RESTORED TO THE LAD. THROUGHOUT THIS PROCEDURE THE PT WAS GIVEN ANGIOMAX, PLAVIX AND INTERGRILIN. THE PT FEELS OKAY, WITH SOME RESIDUAL DISCOMFORT. NO ADDITIONAL EVENT OR PT INFO WAS PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 0031061

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 3.5 X 12 (PART 1009542-12B, LOT 9120142)| 3.0 X 12 (PART 1009541-12B, LOT 0011342)| (PART 1009542-15B, LOT 0012241)| STENT: PROMUS (X3) 3.5 X 15