BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTE GUIDEWIRE

    MDR report key: 4131246 · Received October 1, 2014

    Report

    Report Number
    2134265-2014-05832
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    October 19, 2010
    Report Date
    September 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K011968
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION 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

    (B)(6) CLINICAL STUDY. SAME CASE AS MDR ID: 2134265-2010-05220, 2134265-2010-05227, 2134265-2010-05228, 2134265-2010-05229. IT WAS REPORTED THAT FOLLOWING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST DISCOMFORT. THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE TREATED 3 LESIONS. THE FIRST TARGET LESION WAS A 50% STENOSED, 4.5X10MM BIFURCATED TARGET LESION LOCATED IN THE LEFT MAIN CORONARY ARTERY EXTENDING INTO THE PROXIMAL LEFT CIRCUMFLEX ARTERY. A 185CM FORTE WIRE WAS USED TO PASS DOWN THE DISTAL SEGMENT OF THE MAJOR MARGINAL BRANCH THEN THE LESION WAS TREATED WITH PLACEMENT OF A 3.5X20MM TAXUS LIBERTE STENT USING A DIRECT STENTING TECHNIQUE AND UTILIZED POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE SECOND TARGET LESION WAS A 75% STENOSED, 3.5X22MM TARGET LESION LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH. TREATMENT PLACED A 3.0X28MM TAXUS LIBERTE STENT USING A DIRECT STENTING TECHNIQUE RESULTING IN 10% RESIDUAL STENOSIS. FOLLOWING STENT PLACEMENT, THE PATIENT DEVELOPED SIGNIFICANT JAW DISCOMFORT AND MILD CHEST DISCOMFORT WHICH WAS TREATED WITH SUBLINGUAL NITROGLYCERINE AND INTRAVENOUS MORPHINE SULPHATE. THE THIRD TARGET LESION WAS A 50% STENOSED, 3.4X52MM LONG LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING INTO THE MID RCA. TREATMENT PLACED TWO OVERLAPPING TAXUS LIBERTE STENTS (3.0X38MM, 3.0X20MM) USING A DIRECT STENTING TECHNIQUE RESULTING IN 0% RESIDUAL STENOSIS. ONE DAY POST THE INDEX PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND POSITIVE TROPONIN ELEVATION CONSISTENT WITH A MYOCARDIAL INFARCTION. THE EVENT WAS TREATED WITH SUBLINGUAL NITROGLYCERIN AND MORPHINE. THE CHEST PAIN RESOLVED AND THE PATIENT WAS DISCHARGED LATER THE SAME DAY ON ASPIRIN AND PRASUGREL. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "POSSIBLY RELATED" TO THE STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612287 FORTE GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE UNK154

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention