BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2111004 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-01979
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 15, 2010
    Report Date
    May 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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

    SAME CASE AS MEDWATCH # (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). A 3.0X38MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS ADVANCED AND THE STENT WAS DEPLOYED. THE PATIENT WAS DISCHARGED ON ASA AND PLAVIX. THREE WEEKS LATER, THE PATIENT UNDERWENT SCHEDULED TREATMENT OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE PROCEDURE, THE PATIENT HAD SHORTNESS OF BREATH, TACHYCARDIA AND BECAME HYPOTENSIVE. FILMS REVEALED THAT THERE WERE NO COMPLICATIONS IN THE LAD, HOWEVER SUBACUTE THROMBOSIS OF THE MID RCA WAS CONFIRMED DISTALLY TO THE PREVIOUSLY PLACED TAXUS LIBERTE STENT. THE PATIENT WAS INTUBATED. A 2.0X15MM APEX BALLOON WAS USED TO DILATE THE MID RCA. NEXT, A 3.0X24 TAXUS LIBERTE SDS WAS ADVANCED BUT COULD NOT CROSS. A 3.0X30MM NON-BSC BALLOON WAS ADVANCED AND FURTHER DILATATION WAS PERFORMED BUT THE TAXUS LIBERTE STILL COULD NOT CROSS. AFTER ANOTHER UNSUCCESSFUL ATTEMPT TO PLACE THE TAXUS LIBERTE, A 3.0X23MM NON-BSC STENT WAS USED AND ALSO FAILED TO CROSS. A 3.5X30MM NON-BSC BALLOON WAS USED FOR MULTIPLE OVERLAPPING INFLATIONS AND A 3.0X15MM NON-BSC SDS CROSSED THROUGH MID VESSEL AND THE STENT WAS DEPLOYED DISTAL TO EXISTING STENTS. FINAL FILMS REVEAL 0% RESIDUAL STENOSIS. THE PT WAS HEMODYNAMICALLY STABLE FOLLOWING STENT PLACEMENT.

    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 H7493893638300 0012816546

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention