BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1884138 · Received October 27, 2010

    Report

    Report Number
    2134265-2010-04823
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    August 19, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATED BY MFR: 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). SAME CASE AS 2134265-2010-04821, 2134265-2010-04822, 2134265-2010-04820. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. DUE TO UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IIIB), THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED A 90% STENOSED AND 20MM LONG TARGET LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. A 2.5X20MM APEX BALLOON WAS ADVANCED AND INFLATED 3 TIMES FOR PREDILATION. THEN A 3.0X28MM DRUG ELUTING STUDY STENT WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. SO A 3.0X15MM MAVERICK BALLOON WAS ADVANCED TO THE LESION FOR ADDITIONAL PREDILATION AND INFLATED 2 TIMES. THE WIRE WAS THEN EXCHANGED AND A 2.5X15MM MAVERICK BALLOON WAS ADVANCED BUT WAS SUBSEQUENTLY REMOVED UNINFLATED. A 1.5MM ROTOBLATOR BURR WAS INSERTED AND 4 PASSES WERE DONE. THEN THE 2.5X15MM MAVERICK WAS REINSERTED AND INFLATED. FOLLOWING THIS, THE 3.0X28MM STUDY STENT WAS RE-ADVANCED TO THE LESION AND SUCCESSFULLY DEPLOYED. CORE LAB ANALYSIS REVEALED A TYPE D SPIRAL DISSECTION FOLLOWING PREDILATION. THE DISSECTION WAS FULLY COVERED BY THE STENT AND COULD NOT BE SEEN IN FINAL IMAGES. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND CLOPIDOGREL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680030

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other 2.5X15MM MAVERICK BALLOON| 2.5X20MM APEX BALLOON| 3.0X28MM PLATINUM STUDY STENT| 3.0X15MM MAVERICK BALLOON