BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX¿

    MDR report key: 2907220 · Received January 10, 2013

    Report

    Report Number
    2134265-2012-08490
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 14, 2010
    Report Date
    December 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PMA# OR 510K# CORRECTED FROM P060008 TO P040016. DESCRIBE EVENT OR PROBLEM , CATALOG/MODEL #, DEVICE LOT NUMBER, DEVICE EXPIRATION DATE, DEVICE MANUFACTURED DATE: UPDATED (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2009, THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH PLACEMENT OF 4.00 X 32 MM TAXUS LIBERTE STENT. IN (B)(6) 2010, THE PATIENT PRESENTED WITH CHEST TIGHTNESS, FATIGUE, RIGHT ARM PAIN AND WAS DIAGNOSED WITH STABLE ANGINA (CCS CLASS: 2). CORONARY ANGIOGRAPHY REVEALED TUBULAR PROXIMAL STENOSIS IN THE RCA STENTED SEGMENT. THE STENOSIS SEVERITY WAS NOT JUDGED TO BE ANGIOGRAPHIC SIGNIFICANT BUT INSTEAD REPRESENTING A MODERATE IN-STENT RESTENOSIS. A TARGET LESION IN THE FIRST OBTUSE MARGINAL BRANCH WAS TREATED WITH PLACEMENT OF OVERLAPPING (3.00 X 16 MM PROXIMAL AND 3.00 X 20 MM DISTAL) TAXUS LIBERTE STENTS. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE NEXT DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DIAMETER OF THE TARGET LESION WAS 4.0MM, THAT THE ENTIRE PROXIMAL SEGMENT OF THE RIGHT CORONARY ARTERY WAS DESCRIBED AS DIFFUSELY DISEASED, AND THAT THE PATIENT WAS DISCHARGED ON LISINOPRIL, PLAVIX, ASA AND ADVIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15065 VERIFLEX¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893532400 0009364737

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other