BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1913105 · Received December 2, 2010

    Report

    Report Number
    2134265-2010-05166
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    January 5, 2010
    Report Date
    November 8, 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 IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. A TAXUS LIBERTE STENT WAS IMPLANTED IN (B)(6) 2009. IN (B)(6) 2010, A FOLLOW-UP CORONARY ANGIOGRAM WAS PERFORMED REVEALING THE 90% STENOSED TARGET LESION LOCATED IN THE 1ST OBTUSE MARGINAL ARTERY, WHICH WAS 2.75MM IN DIAMETER AND 10MM LONG. A TARGET VESSEL REINTERVENTION WAS PERFORMED ONE WEEK LATER WITH BALLOON DILATION OF THE LESION, WHICH RESULTED IN 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. THE PATIENT HAD NO ISCHEMIC SYMPTOMS AT THE EVENT. FOLLOW-UP WAS PERFORMED IN (B)(6) 2010. THE PATIENT HAD NO ANGINAL SYMPTOMS. IN (B)(6) 2010, 1 YEAR FOLLOW-UP WAS PERFORMED AND THE PATIENT HAD NO ANGINAL SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE, A NEW LESION WITH A REFERENCED VESSEL DIAMETER OF 2.0MM, 10.0MM LONG AND 75% STENOSED IN THE 1ST OBTUSE MARGINAL WAS NOTED. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.75X12MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW NOTED. THE PATIENT WAS DISCHARGED 2 DAYS LATER WITHOUT COMPLICATIONS ON ASPIRIN AND CLOPIDOGREL BISULFATE.

    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 76 YR Required Intervention