BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1953012 · Received January 7, 2011

    Report

    Report Number
    2134265-2010-05722
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    May 25, 2010
    Report Date
    December 13, 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)(6). SAME CASE AS: 2134265-2010-05721. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. DURING THE INDEX PROCEDURE, THE LESIONS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) AND PROXIMAL LEFT ANTERIOR DESCENDING (LAD) WERE TREATED WITH UNKNOWN SIZE TAXUS LIBERTE STENTS. IN (B)(6), FOLLOW-UP CORONARY ANGIOGRAM REVEALED RESTENOSIS OF THE MID RCA AND PROXIMAL LAD. LESION 1 WAS LOCATED IN THE MID RCA. THE LESION WAS 50% STENOSED AND 2.5MM IN DIAMETER. LESION 2 WAS LOCATED IN THE PROXIMAL LAD. THE LESION WAS 90% STENOSED AND 3.0MM IN DIAMETER. IN (B)(6) 2010 A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. THE PATIENT HAD NO ISCHEMIC SYMPTOMS AT THE EVENT. LESION 1 WAS 75% STENOSED, 2.5MM IN DIAMETER AND 15MM LONG. THE LESION WAS DILATED WITH AN UNKNOWN BALLOON CATHETER. RESIDUAL STENOSIS WAS 25%. LESION 2 WAS 75% STENOSED, 2.5MM IN DIAMETER AND 15MM LONG. THE LESION WAS DILATED WITH AN UNKNOWN BALLOON CATHETER. RESIDUAL STENOSIS WAS 25%. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS LISTED AS IMPROVED. IN (B)(6) 2010, A 1 YEAR FOLLOW-UP WAS PERFORMED. THE PATIENT HAD NO ANGINAL SYMPTOMS.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2011-02942. IT WAS FURTHER REPORTED THAT TWO UNKNOWN SIZE TAXUS LIBERTE STENTS WERE IMPLANTED IN THE MID RCA INSTEAD OF ONE TAXUS LIBERTE STENT AS INITIALLY REPORTED. PER PHYSICIAN COMMENTS, "THE CORONARY RESTENOSIS WAS CAUSED BY THE PROXIMAL SIDE STENT."

    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 Required Intervention