BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTOME CUTTING BALLOON

    MDR report key: 1801679 · Received August 16, 2010

    Report

    Report Number
    2134265-2010-03768
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    June 25, 2009
    Report Date
    July 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (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)(6). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE PATIENT PRESENTED WITH RECURRENT ANGINA AND SHORTNESS OF BREATH ON EXERTION AND WAS ADMITTED INTO THE HOSPITAL. SOURCE DOCUMENTS INDICATED THAT THE PATIENT HAD DISCONTINUED HIS MEDICATIONS EXCEPT FOR ASPIRIN OVER A YEAR AGO. CARDIAC CATHETERIZATION WAS RECOMMENDED AND REVEALED A WIDELY PATENT STENT IN THE MID PORTION OF THE RCA WITH A 60-70% STENOSIS PROXIMAL TO THE PREVIOUSLY PLACED MID DISTAL STENT IN THE RCA. TREATMENT WAS PERFORMED UTILIZING PRE-DILATION USING A FLEXTOME CUTTING BALLOON. HOWEVER CORE LAB INFORMATION NOTED THAT A SMALL GRADE B VESSEL DISSECTION OCCURRED AFTER PRE-DILATION AT THE OSTIUM SEGMENT OF THE RCA. A 2.75X28MM PROMUS WAS PLACED TO OVERLAP THE PREVIOUSLY PLACED STUDY STENT AND A 3.0X18MM PROMUS STENT WAS USED FOR BAILOUT TREATMENT BEING PLACED PROXIMAL TO THE CURRENT STENT AND OVERLAPPING TO EXTEND INTO THE OSTIUM. BOTH STENTS WERE POST DILATED RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTOME CUTTING BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749CBO3250150

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention