BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1953028 · Received January 7, 2011

    Report

    Report Number
    2134265-2010-05720
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    March 8, 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

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2009, THE TARGET LESION BEING TREATED WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS 95% STENOSED, 2.5MM IN DIAMETER AND 40MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF TWO TAXUS LIBERTE STENTS (2.5X28MM AND 2.5X24MM) WITHOUT GAP. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW NOTED. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS 2 DAYS LATER ON ASPIRIN AND CLOPIDOGREL BISULFATE. IN MARCH 2010, IT WAS CONFIRMED THE PATIENT EXPERIENCED CHEST PAIN.

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. DURING THE INDEX PROCEDURE, THE LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH AN UNKNOWN SIZE TAXUS LIBERTE STENT. IN (B)(6) 2010, A FOLLOW-UP CORONARY ANGIOGRAM WAS PERFORMED. IT WAS NOTED THAT THE PATIENT EXPERIENCED RESTENOSIS. THE 90% STENOSED TARGET LESION LOCATED IN THE MID RCA WAS 2.5MM IN DIAMETER AND 20MM LONG. AN INTERVENTION WAS PERFOMED IN THE MID RCA. STABLE ANGINA SYMPTOM WAS ALSO NOTED AT THE EVENT. THE LESION WAS TREATED WITH PLACEMENT OF A PROMUS STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 30%. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S OUTCOME IS RESOLVED. IN (B)(6) 2010, 1 YEAR FOLLOW-UP WAS PERFORMED. THE PATIENT HAD NO ANGINAL SYMPTOMS.

    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 81 YR Required Intervention