BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3000477 · Received March 12, 2013

    Report

    Report Number
    2134265-2013-01410
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 15, 2012
    Report Date
    February 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THE FOLLOWING LOT NUMBERS WERE PROVIDED, HOWEVER IT IS NOT KNOWN WHICH ONE OF THESE THREE DEVICES WAS IMPLANTED IN THE LAD: 2.25X16MM TAXUS LIBERTE BATCH 13801408, 2.25X24MM TAXUS LIBERTE BATCH 13878723, 2.25X08MM TAXUS LIBERTE BATCH 13946624, 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). IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION, IN-STENT RESTENOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. ONE TAXUS LIBERTE STENT WAS PLATED IN THE LAD LESION. TWO TAXUS LIBERTE STENTS WERE PLACED IN THE RIGHT POSTEROLATERAL BRANCH. POST PROCEDURE RESIDUAL STENOSIS WAS 1% WITH TIMI III FLOW. PATIENT WAS DISCHARGED ON CLOPIDOGREL AND ASPIRIN. TWO HUNDRED EIGHTY FIVE DAYS POST INDEX PROCEDURE PATIENT WAS ADMITTED TO THE HOSPITAL WITH RECURRENT CHEST PAIN AND RESPIRATORY DISTRESS. INTRAVASCULAR ULTRASOUND (IVUS) REVEALED 90% RESTENOSIS OF THE STUDY SENT IMPLANTED IN THE MID LAD ARTERY. RESTENOSIS WAS TREATED WITH BALLOON ANGIOPLASTY, RESULTING IN 10% STENOSIS AND BRISK ANTEGRADE FLOW. BALLOON DILATION WAS ALSO PERFORMED ON THE 95% STENOSED RAMUS ARTERY RESULTING IN 20% RESIDUAL STENOSIS AND BRISK ANTEGRADE FLOW. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. PATIENT WAS DISCHARGED ON ASPIRIN, BETA-BLOCKER, AND PLAVIX.

    Description of Event or Problem · 1

    (B)(4) STUDY: IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION, IN-STENT RESTENOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. ONE TAXUS LIBERTE STENT WAS PLATED IN THE LAD LESION. TWO TAXUS LIBERTE STENTS WERE PLACED IN THE RIGHT POSTEROLATERAL BRANCH. POST PROCEDURE RESIDUAL STENOSIS WAS 1% WITH TIMI III FLOW. PATIENT WAS DISCHARGED ON CLOPIDOGREL AND ASPIRIN. AT 285 DAYS POST INDEX PROCEDURE PATIENT WAS ADMITTED TO THE HOSPITAL WITH RECURRENT CHEST PAIN AND RESPIRATORY DISTRESS. INTRAVASCULAR ULTRASOUND (IVUS) REVEALED 90% RESTENOSIS OF THE STUDY SENT IMPLANTED IN THE MID LAD ARTERY. RESTENOSIS WAS TREATED WITH BALLOON ANGIOPLASTY, RESULTING IN 10% STENOSIS AND BRISK ANTEGRADE FLOW. BALLOON DILATION WAS ALSO PERFORMED ON THE 95% STENOSED RAMUS ARTERY RESULTING IN 20% RESIDUAL STENOSIS AND BRISK ANTEGRADE FLOW. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. PATIENT WAS DISCHARGED ON ASPIRIN, BETA-BLOCKER, AND PLAVIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103185 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention