BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1833353 · Received September 14, 2010

    Report

    Report Number
    2134265-2010-04215
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    November 6, 2009
    Report Date
    August 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    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

    (B)(4). IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. THE TARGET LESION BEING TREATED WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). FOLLOW-UP CORONARY ANGIOGRAM WAS PERFORMED. THE LESION WAS 75% STENOSED, 3.00MM IN DIAMETER AND 33.0MM LONG. IN (B)(6) 2009, RESTENOSIS WAS CONFIRMED. A TARGET VESSEL RE-INTERVENTION WAS PERFORMED WITH AN UNKNOWN BALLOON CATHETER AND A NON-BSC STENT. POST PROCEDURE VISUAL INSPECTION REVEALED 0% STENOSIS. THE EVENT WAS CONSIDERED RESOLVED 1 DAY LATER. IN (B)(6) 2010, 1 YEAR FOLLOW-UP WAS PERFORMED AND THE PATIENT HAD NO ANGINAL SYMPTOM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE, A NEW LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY WAS 90% STENOSED, 3.0MM IN DIAMETER AND 20MM LONG. THE LESION WAS TREATED WITH PLACEMENT OF A 3.0X20MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW NOTED. THE PATIENT WAS DISCHARGED 5 DAYS LATER WITHOUT COMPLICATIONS ON ASPIRIN AND TICLOPIDINE HYDROCHLORIDE.

    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 - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention