BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1939835 · Received December 28, 2010

    Report

    Report Number
    2134265-2010-05861
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    February 26, 2010
    Report Date
    December 2, 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

    DESCRIBE EVENT AND OTHER RELEVANT HISTORY UPDATED. (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) CLINICAL STUDY. SAME CASE AS MFR.# 2134265-2010-04275 AND 2134265-2010-04276. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. DURING THE INDEX PROCEDURE IN (B)(6) 2009, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED TO TREAT TWO LESIONS LOCATED IN MID RIGHT CORONARY ARTERY (RCA) AND RIGHT ATRIOVENTRICULAR BRANCH (R-PAV). LESION 1 WAS LOCATED IN THE MID RCA WAS 90% STENOSED, 3.5MM IN DIAMETER AND 30MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF TWO 3.5X32MM TAXUS LIBERTE STENTS WITHOUT GAP. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. LESION 2 WAS LOCATED IN THE R-PAV WAS 90% STENOSED, 3.0MM IN DIAMETER AND 16MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.0X16MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. THE PATIENT WAS DISCHARGED 3 DAYS LATER WITHOUT COMPLICATIONS ON ASPIRIN, CLOPIDOGREL BISULFATE AND BERAPROST SODIUM. IN (B)(6) 2010, A FOLLOW-UP CORONARY ANGIOGRAM CONFIRMED RESTENOSIS IN THE MID RCA, R-PAV AND STENOSIS IN THE 1ST DIAGONAL. THE PATIENT HAD NO ISCHEMIC SYMPTOM. LESION 1 WAS 90% STENOSED, 3.5MM IN DIAMETER AND 30MM LONG. THE LESION WAS TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA). RESIDUAL STENOSIS WAS 25% WITH TIMI 3 FLOW. LESION 2 WAS 90% STENOSED, 3.0MM IN DIAMETER AND 16MM LONG. THE LESION WAS TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA). RESIDUAL STENOSIS WAS 25% WITH TIMI FLOW 3. THE LESION LOCATED IN THE 1ST DIAGONAL WAS TREATED WITH PLACEMENT OF A NON-BSC STENT. THE EVENTS LOCATED IN THE MID RCA AND R-PAV WAS SUBSIDED AND THE STENOSIS IN THE 1ST DIAGONAL WAS CONSIDERED RESOLVED. THE PATIENT WAS DISCHARGED 2 DAYS LATER.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT LESION 1 AND LESION 2 WERE DE NOVO LESIONS. THE MID RIGHT CORONARY ARTERY WAS TREATED AND TIMI FLOW GRADE REMAINED 3.

    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 53 YR Required Intervention