BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1930831 · Received December 16, 2010

    Report

    Report Number
    2134265-2010-05590
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THROMBOSIS OCCURRED. THE PATIENT UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED 2 TARGET LESIONS. THE FIRST WAS A 75% STENOSED AND 18MM LONG LESION LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. IT WAS TREATED WITH DIRECT STENT PLACEMENT OF A 4.0X20MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-2 FLOW. SLOW FLOW WAS PRESENT AND A THROMBUS WAS IDENTIFIED. THIS WAS TREATED WITH THROMBECTOMY. THE SECOND LESION WAS A 75% STENOSED AND 10MM LONG LESION LOCATED IN THE SVG TO THE PROXIMAL RCA WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. IT WAS TREATED WITH DIRECT STENT PLACEMENT OF A 4.0X12MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THROMBOSIS DID NOT OCCUR AS PREVIOUSLY REPORTED. RATHER, DEVICE WATERMELON SEED ACTION OCCURRED. THE FIRST LESION LOCATED IN THE SAPHENOUS VEIN GRAFT TO THE PROXIMAL RIGHT CORONARY ARTERY WAS TREATED WITH DIRECT STENT PLACEMENT OF A 4.0X20MM TAXUS LIBERTE STENT. THE SITE IS NOW REPORTING THAT RESIDUAL STENOSIS WAS 20% AND TIMI-2 FLOW WAS OBSERVED. IT WAS PREVIOUSLY REPORTED THAT THERE WAS 0% RESIDUAL STENOSIS. IT WAS NOTED THAT "THIS WAS NOT AN OVERSIZED STENT IN A LARGE GRAFT; HOWEVER, SOME WATERMELON SEED ACTION OCCURRED, FORCING THE STENT PROXIMAL. THERE WAS IMMEDIATE POOR REFLOW DISTALLY. THE FILTER WIRE WAS REMOVED. SLOW REFLOW PERSISTED." ASPIRATION THROMBECTOMY WAS PERFORMED AND THE PATIENT WAS GIVEN ADENOSINE AND BLOOD. THE SITE REPORTS "THERE WAS STILL AN INTERMEDIATE LESION IN THE PROXIMAL IN-STENT RESTENOTIC SEGMENT WHERE THE STENT HAD WATERMELON SEEDED." AFTER THE SECOND LESION WAS TREATED, SLOW FLOW PERSISTED SO THE PATIENT WAS AGAIN GIVEN ADENOSINE AND BLOOD RESULTING IN "SLOW FLOW BUT RETURNED FLOW." DUE TO MODERATE ST DEPRESSION, AN INTRA AORITC BALLOON PUMP WAS PLACED.

    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 H7493893720400 0013327703

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 4.0X12MM TAXUS LIBERTE STENT