BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2112094 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-02074
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    September 22, 2010
    Report Date
    May 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MADE CORRECTION TO AE OR PRODUCT PROBLEM FROM 'REPORTED ISSUE IS BOTH AN ADVERSE EVENT AND A PRODUCT PROBLEM' TO 'ADVERSE EVENT.'

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW FOR THIS DEVICE CONFIRMED THAT THE DEVICE MET ALL APPLICABLE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2011-02075 AND 2134265-2011-01954. VOLUNTARY MEDWATCH #(B)(4). IT WAS REPORTED THAT SUBSEQUENT TO A STENTING TREATMENT PROCEDURE STENT THROMBOSIS AND ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) OCCURRED. THE 100% STENOSED LESION BEING TREATED WAS LOCATED IN THE MID TO PROXIMAL RIGHT CORONARY ARTERY (RCA). THROMBECTOMY WAS PERFORMED AND TWO 2.75X38MM AND A 2.75X20MM TAXUS LIBERTE STENTS WERE SUCCESSFULLY DEPLOYED. THE PATIENT WAS DISCHARGED ON ACETYLSALICYLIC ACID (ASA) AND PRASUGREL. IN (B)(6) OF 2010, THE PATIENT WAS RE-ADMITTED WITH STEMI AND ANGIOGRAPHY SHOWING 80% OCCLUSION WITH THROMBOSIS IN THE TAXUS LIBERTE STENT PLACED IN THE PROXIMAL RCA. A 3.0X10MM FLEXTOME CUTTING BALLOON WAS ADVANCED TO THE LESION AND INFLATED. NEXT A 3.0X38MM TAXUS LIBERTE STENT WAS ADVANCED AND DEPLOYED FROM THE PROXIMAL TO MID RCA. IT WAS DETERMINED THAT HE PATIENT "HAD BEEN NON-COMPLIANT WITH MEDS FOR 2 MONTHS PRIOR TO PRESENTATION." NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS "DISCHARGED ON ASA AND PRASUGREL WITH EXTENSIVE DISCUSSION OF IMPORTANCE OF MEDICAL COMPLIANCE."

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2011-02075 AND 2134265-2011-01954. VOLUNTARY MEDWATCH #(B)(4). IT WAS REPORTED THAT SUBSEQUENT TO A STENTING TREATMENT PROCEDURE STENT THROMBOSIS AND ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) OCCURRED. THE 100% STENOSED LESION BEING TREATED WAS LOCATED IN THE MID TO PROXIMAL RIGHT CORONARY ARTERY (RCA). THROMBECTOMY WAS PERFORMED AND TWO 2.75X38MM AND A 2.75X20MM TAXUS LIBERTE STENTS WERE SUCCESSFULLY DEPLOYED. THE PATIENT WAS DISCHARGED ON ACETYLSALICYLIC ACID (ASA) AND PRASUGREL. IN (B)(6) OF 2010, THE PATIENT WAS RE-ADMITTED WITH STEMI AND ANGIOGRAPHY SHOWING 80% OCCLUSION WITH THROMBOSIS IN THE TAXUS LIBERTE STENT PLACED IN THE PROXIMAL RCA. A 3.0X10MM FLEXTOME CUTTING BALLOON WAS ADVANCED TO THE LESION AND INFLATED. NEXT A 3.0X38MM TAXUS LIBERTE STENT WAS ADVANCED AND DEPLOYED FROM THE PROXIMAL TO MID RCA. IT WAS DETERMINED THAT HE PATIENT "HAD BEEN NON-COMPLIANT WITH MEDS FOR 2 MONTHS PRIOR TO PRESENTATION." NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS "DISCHARGED ON ASA AND PRASUGREL WITH EXTENSIVE DISCUSSION OF IMPORTANCE OF MEDICAL COMPLIANCE."

    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 - MAPLE GROVE H7493893620270 13154433

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 2.75X38 TAXUS LIBERTE STENT X2