BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3052419 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02123
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    September 5, 2012
    Report Date
    March 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    UF/VOLUNTARY # (B)(6). IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, RESPIRATORY FAILURE, PULMONARY EDEMA, MYOCARDIAL INFARCTION AND STENT THROMBOSIS OCCURRED. THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND CARDIAC HEART FAILURE AND WAS TRANSFERRED FROM AN OUTLYING FACILITY. ANGIOGRAPHY REVEALED A 99% STENOSED TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0X12MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED WITH GOOD RESULT. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PLAVIX. IN (B)(6) 2012, THE PATIENT WAS TRANSFERRED FROM AN OUTLYING FACILITY WITH NEW ONSET RESPIRATORY FAILURE, PULMONARY EDEMA AND A QUESTION OF PNEUMONIA. THE PATIENT DID NOT COMPLAIN OF CHEST PAIN. IT WAS NOTED THAT THE PATIENT STOPPED TAKING PLAVIX JUST A FEW DAYS AFTER THE INITIAL PROCEDURE DISCHARGE, BECAUSE IT MADE HIM "JITTERY AND ITCHY". INITIALLY THE PATIENT'S CARDIAC ENZYMES WERE NORMAL, BUT SUBSEQUENTLY ROSE AND NON-STEMI WAS DIAGNOSED. ANGIOGRAPHY REVEALED A THROMBUS OCCLUDING 95% OF THE PREVIOUSLY PLACED STENT LOCATED IN THE MID LAD. A THROMBECTOMY WAS PERFORMED AND A 3.25X15MM NC QUANTUM APEX BALLOON WAS USED TO RESTORE TIMI 3 FLOW AND 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PLAVIX WITH INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156501 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412300 15076305

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention