BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX BALLOON CATHETER

    MDR report key: 2111913 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-02301
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    August 20, 2010
    Report Date
    May 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    (B)(4) STUDY. SAME PATIENT AS: 2134265-2010-04258, 2134265-2011-00813. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED SLOW FLOW. THE TARGET LESION BEING TREATED WAS LOCATED IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY(RCA). THE LESION WAS 90% STENOSED, 4.0MM IN DIAMETER AND 24MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 4.0X16MM AND 3.5X24MM TAXUS LIBERTE STENTS. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. DURING THE PROCEDURE, POST DEPLOYMENT INTRAVASCULAR ULTRASOUND (IVUS) WAS USED WHICH NOTED STENT UNDER-EXPANSION. POST DILATION WAS PERFORMED WITH A NON-COMPLAINT BALLOON. RESIDUAL STENOSIS WAS 0%. SOURCE NOTES INDICATED THAT "WITH INITIAL BALLOON INFLATION, THERE WAS TRANSIENT SLOW FLOW THROUGHOUT THE VESSEL SYSTEM WITH SOME EVIDENT SIDE BRANCH CUTOFF." THE PATIENT WAS TREATED MEDICALLY. POST INDEX PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND ELEVATED CARDIAC ENZYMES CONSISTENT WITH MYOCARDIAL INFARCTION. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK21

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention