BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2042500 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01217
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    December 3, 2009
    Report Date
    March 9, 2011
    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 A COMBINATION PRODUCT DEVICE EVALUATED BY MANUFACTURER: 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

    IT WAS FURTHER REPORTED THAT THE LESION BEING TREATED IN THE INDEX PROCEDURE WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY.

    Description of Event or Problem · 1

    TAXUS EXPRESS2 PMSS CLINICAL STUDY. SAME CASE AS 2134265-2011-01216 AND 2134265-2011-01218. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. THE DENOVO LESION WAS 75% STENOSIS, 40MM LONG WITH A DIAMETER OF 2.75. PRE-DILATATION WAS PERFORMED WITH 2.5X15MM BALLOON(12ATM). THE PHYSICIAN THEN IMPLANTED THREE (2.5X24MM, 2.75X32MM AND 3.0X16MM) TAXUS EXPRESS2 STENTS IN THE TARGET LESION. NO POST-DILATATION WAS PERFORMED, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW 3. THE PATIENT WAS DISCHARGED ON PLAVIX, PLETAAL AND BAYASPIRIN. AT THE FOLLOW-UP VISIT IN (B)(6) 2009, RESTENOSIS WAS CONFIRMED. THE ANGIOGRAPHY SHOWED THE LESION WAS 75% STENOSED, 10.0MM LONG WITH A DIAMETER OF 3.0MM. PCI WITH BALLOONING WAS PERFORMED. RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW 3. THE PATIENT WAS DISCHARGED 2 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 H7493897032270 11240722

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 3.00X16MM TAXUS EXPRESS2 STENT| 2.50X24MM TAXUS EXPRESS2 STENT