BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1941363 · Received December 29, 2010

    Report

    Report Number
    2134265-2010-05759
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    May 20, 2010
    Report Date
    December 6, 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 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

    PATIENT IDENTIFIER, DATE OF BIRTH, PATIENT SEX, DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LAB DATA, OTHER RELEVANT HISTORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE INDEX PROCEDURE TREATED THE 99% STENOSED, 3.0X25MM TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. TREATMENT CONSISTED OF PRE-DILATION, THE PLACEMENT OF A 3.0X28MM TAXUS LIBERTE STUDY STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. AFTER THE PERFORMANCE OF A UNSPECIFIED STAGED PROCEDURE IN (B)(6) 2009, THE PATIENT WAS DISCHARGED WITHOUT COMPLICATION ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2010, THE REVASCULARIZATION PROCEDURE ALSO USED ANGIOPLASTY. THE PATIENT WAS DISCHARGED TWO DAYS LATER. PER THE PHYSICIAN, THE RESTENOSIS WAS LISTED AS "POSSIBLY RELATED" TO THE STUDY STENT.

    Description of Event or Problem · 1

    (B)(4) POST MARKET SURVEILLANCE STUDY. IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH IN STENT RESTENOSIS. THE INDEX PROCEDURE PLACED AN UNSPECIFIED TAXUS LIBERTE STENT IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. IN (B)(6) 2010, WITH NO ISCHEMIC SYMPTOM, A CT SCAN REVEALED RESTENOSIS IN THE MID LAD. IN (B)(6) 2010, ANGIOGRAPHY REVEALED A 90% RESTENOSED, 2.5X20MM TARGET LESION LOCATED IN THE MID LAD. TREATMENT THE SAME DAY PLACED AN UNSPECIFIED NON BSC STENT RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT OUTCOME WAS LISTED AS "IMPROVED" THE SAME DAY. IN (B)(6) 2010, THE PATIENT EXPERIENCED ANEMIA. IN (B)(6) 2010, A GASTROINTESTINAL FIBERSCOPE AND CT SCANNING WERE PERFORMED BUT A BLEEDING SOURCE WAS NOT FOUND AND THE PATIENT SHOWED IMPROVED SYMPTOM WITH MEDICATION. PER THE PHYSICIAN THE ANEMIA WAS NOT RELATED TO THE TAXUS STENT. THE PATIENT HAD NO ANGINAL SYMPTOMS AT THE 9 MONTH AND 1 YEAR STUDY FOLLOW UP VISITS.

    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 Hospitalization| R