BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1961412 · Received January 14, 2011

    Report

    Report Number
    2134265-2010-05942
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) CLINICAL STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED ANGINA. THE TARGET LESION WAS A BIFURCATED LESION LOCATED IN THE DISTAL CIRCUMFLEX WITH 99% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.25 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 3.00MM X 20MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE TWO DAYS LATER ON ASPIRIN AND PRASUGREL. A 104 DAYS POST INDEX PROCEDURE, THE PATIENT DEVELOPED ANGINA AND WAS HOSPITALIZED. CORONARY ANGIOGRAPHY REVEALED IN-STENT RESTENOSIS AND A TARGET VESSEL REINTERVENTION WAS PERFORMED. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED TWO DAYS LATER ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT CORONARY ANGIOGRAPHY REVEALED IN-STENT RESTENOSIS AND THE LCX WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.75 X 18 MM NON BSC STENT WITH 0% RESIDUAL STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620300 0013157016

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R