BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® EXPRESS²®

    MDR report key: 2566829 · Received May 9, 2012

    Report

    Report Number
    2134265-2012-02480
    Event Type
    Injury
    Date Received
    May 9, 2012
    Date of Event
    September 27, 2011
    Report Date
    April 11, 2012
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. 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. THE MANUFACTURING BATCH RECORD REVIEW CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED PATIENT EFFECTS ARE LISTED AS POTENTIAL ADVERSE EVENTS IN THE PRODUCT DIRECTIONS FOR USE. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN OCT 2008, CLINICAL STATUS ASSESSMENT INDICATED THE PATIENT'S QUALIFYING CONDITION AS STABLE ANGINA PECTORIS (CCS CLASS I), WITH 49% LVEF AND TIMI FLOW 3. THE RESTENOSED TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (DIST RCA) WITH 90% STENOSIS AND WAS 45.0MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF THREE TAXUS EXPRESS2 STENTS, WITH 25% RESIDUAL STENOSIS FOLLOWING POST-DILATION. TIMI 3 REMAINED UNCHANGED THROUGHOUT THE PROCEDURE. IN (B)(6) 2011, THE PATIENT HAD WORSENING OF UNSTABLE ANGINA PECTORIS ASSOCIATED WITH ISCHEMIC SYMPTOMS AND POSITIVE MYOCARDIAL PERFUSION SCINTIGRAPHY. A CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE WAS PERFORMED IN (B)(6) 2012. TWO WEEKS LATER, THE "WORSENING OF ANGINA" SUBSIDED AND THE PATIENT WAS DISCHARGED.

    Description of Event or Problem · 1

    (B)(6). SAME PATIENT AS MDR ID#: 2134265-2012-02482, 2134265-2012-02483. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT HAD WORSENING OF ANGINA PESTORIS. THE LESION BEING TREATED WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (DIST RCA). THE TARGET LESION WAS TREATED WITH PLACEMENT OF THREE TAXUS EXPRESS2 STENTS WITH SIZE OF 2.75X16MM, 3.00X16MM, AND 3.00X16MM. THE PATIENT WAS DISCHARGED ON PARACLODIN AND WARFARIN. IN (B)(6) 2011, THE PATIENT HAD WORSENING OF ANGINA PESTORIS AND REQUIRED A CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON THE DIST RCA WHICH HAD A 90% STENOSED, 6.0MM LONG LESION WITH A VESSEL DIAMETER OF 3.00MM. IT WAS REPORTED THE OUTCOME WAS IMPROVED IN (B)(6) 2012. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® EXPRESS²® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897016270 11070044

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R