BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1162095 · Received September 16, 2008

    Report

    Report Number
    2134265-2008-02654
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    May 3, 2006
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THIS REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL REGISTRY. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE, A DISSECTION OCCURRED. PRIOR TO THE EVENT, THE PHYSICIAN SUCCESSFULLY TREATED LESIONS IN THE PROXIMAL CIRCUMFLEX AND PROXIMAL RIGHT CORONARY ARTERY (RCA) WITHOUT DIFFICULTIES. NEXT, THE PHYSICIAN TREATED A BIFURCATED LESION IN THE DISTAL RCA/INFERIOR SEPTAL ARTERY. THE LESION MEASURED 3.0X32MM, WAS 80% STENOSED WITH MODERATE CALCIFICATION. THE LESION WAS PRE-DILATED WITH A 2.50X15MM MAVERICK BALLOON. DURING PRE-DILATATION A TYPE B DISSECTION OCCURRED. THE PHYSICIAN ATTEMPTED TO TREAT THE LESION WITH A 3.0X32MM TAXUS LIBERTE STENT, HOWEVER, IT WOULD NOT CROSS THE LESION. THE PHYSICIAN WAS ABLE TO CROSS WITH A 3.00X20MM TAXUS LIBERTE STENT. ADDITIONALLY, THE PHYSICIAN PLACED A 3.00X12MM TAXUS LIBERTE BAILOUT STENT IN THE INFERIOR SEPTAL ARTERY. FOLLOWING TREATMENT, RESIDUAL STENOSIS WAS 10% WITH TIMI - 3 FLOW. THE PT WAS DISCHARGED THE FOLLOWING DAY ON CLOPIDOGREL AND ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention