BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3013485 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01525
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    December 6, 2010
    Report Date
    February 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS 2134265-2013-01526. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST AND JAW PAIN. LESION 1 WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 80% STENOSIS AND WAS 24 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 24 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. LESION 2 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 80% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT USING A 2.50 X 12 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. THE TWO STUDY STENTS DID NOT OVERLAP. THE NEXT DAY, THE PATIENT EXPERIENCED CHEST AND LEFT JAW PAIN RATED 10 OUT OF 10 WHICH WAS TREATED MEDICALLY. THE PATIENT'S CHEST AND LEFT JAW PAIN WAS NOTED TO BE IMPROVED (RATED AS 3 OUT OF 10) WHICH WAS TOLERABLE. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116537 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893624350 12805674

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention 2.50X12MM TAXUS LIBERTE STENT