BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1781455 · Received August 3, 2010

    Report

    Report Number
    2134265-2010-03339
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    August 22, 2009
    Report Date
    July 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: AS THE DEVICE HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE (CIS) COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. 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 PATIENT AS 2134265-2009-04691. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING PROCEDURE THE PATIENT EXPERIENCED RESTENOSIS. THE TARGET LESION WAS A 3.50MM, 75% STENOSED, 15.0MM LONG PORTION OF THE PROXIMAL LEFT ANTERIOR DESCENDING (PROX LAD). THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT OF A 3.5X28MM TAXUS EXPRESS2 STUDY STENT AT MAXIMUM 16.0 ATMS IN THE LESION. THE STENT WAS POST-DILATED BY THE STENT DELIVERY BALLOON AT MAXIMUM 16.0 ATMS. POST-IVUS WAS PERFORMED. THE STENT WAS WELL POSITIONED AND WELL EXPANDED (0% RESIDUAL STENOSIS). THE PATIENT WAS DISCHARGED 3 DAYS LATER ON TICPILONE AND ASPIRIN. IN (B)(6) 2009, THE PATIENT EXPERIENCED A SECOND EPISODE OF RESTENOSIS IN THE PROX LAD. THE PATIENT DID NOT HAVE ANY ISCHEMIC SYMPTOMS. THE LESION WAS 3.5X21MM AND 90% STENOSED. A NON BSC STENT OF UNKNOWN SIZE WAS IMPLANTED IN THE TARGET LESION. THE PATIENT WAS DISCHARGED 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897028350 9532423

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention