BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1833482 · Received September 14, 2010

    Report

    Report Number
    2134265-2010-04216
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    April 26, 2010
    Report Date
    August 24, 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

    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). SAME CASE AS 2134265-2010-04239. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. TARGET LESION 1 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). ON AN UNKNOWN DATE, THE PHYSICIAN IMPLANTED AN UNKNOWN SIZE TAXUS LIBERTE STENT. TARGET LESION 2 WAS LOCATED IN THE MID RCA. THE PHYSICIAN IMPLANTED AN UNKNOWN SIZE TAXUS LIBERTE STENT IN THE LESION. IN (B)(6) 2010, THE PATIENT HAD A 9 MONTH FOLLOW-UP WITH NO COMPLAINT OF ANGINAL SYMPTOMS. FOLLOW-UP ANGIOGRAPHY WAS PERFORMED WHICH SHOWED THE PROXIMAL RCA WAS 3.00MM WITH 99% STENOSIS, AND THE MID RCA WAS 2.50MM WITH 0% STENOSIS. THE PHYSICIAN IMPLANTED A NON BSC STENT OF UNKNOWN SIZE. THE PROCEDURE STENOSIS WAS 25%. THE PATIENT WAS DISCHARGED 2 DAYS LATER. AT THE 1-YEAR FOLLOW-UP, THE PATIENT HAD NO ANGINAL SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LESIONS WERE LOCATED IN PROXIMAL RIGHT CORONARY ARTERY (PROX RCA) AND THE MID RIGHT CORONARY ARTERY (MID RCA) AND WERE TREATED WITH PCI. THE LESION LOCATED IN THE PROX RCA HAD A REFERENCE VESSEL DIAMETER OF 3.00 MM AND A LENGTH OF 32.0 MM WAS 100% STENOSED. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION, AND IMPLANTING A 3.00X32 MM TAXUS LIBERTE STENT AND POST-DILATATION. RESIDUAL STENOSIS BECAME 25% AND TIMI FLOW IMPROVED FROM 0 TO 3. THE IN THE MID RCA HAD A REFERENCE VESSEL DIAMETER OF 2.50 MM AND A LENGTH OF 32.0 MM AND WAS 100% STENOSED. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 2.50X32 MM TAXUS LIBERTE STENT AND POST-DILATATION. RESIDUAL STENOSIS BECAME 25% AND TIMI FLOW IMPROVED FROM 0 TO 3. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS 2 DAYS POST INDEX PROCEDURE ON ASPIRIN, TICLOPIDINE HYDROCHLORIDE, AND WARFARIN POTASSIUM. AT THE TIME OF THE EVENT THE LESION IN THE PROX RCA HAD A LENGTH OF 15.0 MM, AND TIMI FLOW IMPROVED FROM 2 TO 3 FOLLOWING THE REINTERVENTION.

    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 78 YR Required Intervention