BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2042523 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01218
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    December 3, 2009
    Report Date
    March 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS 2134265-2011-01216 AND 2134265-2011-01217. 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) (B)(4) STENTS IN THE TARGET LESION. NO POST-DILATATION WAS PERFORMED, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW 3. THE PATIENT WAS DISCHARGED ON PLAVIX, PLETAL 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.

    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.

    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 - MAPLE GROVE H7493897016300 11779303

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 2.75X32MM (B)(4) STENT| 2.50X24MM (B)(4) STENT