BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R) ATOM (TM)

    MDR report key: 2123182 · Received June 14, 2011

    Report

    Report Number
    2134265-2011-02204
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE TAXUS LIBERTE ATOM STENT DELIVERY SYSTEM (SDS) WAS RECEIVED IN A COMPETITORS GUIDE CATHETER SHELF BOX. THE STENT WAS NOT RETURNED WITH THE SDS. THE HYPOTUBE PORTION OF THE SDS WAS BENT/KINKED IN SEVERAL PLACES. MAGNIFIED INSPECTION CONFIRMED THE REPORTED DISLODGEMENT OF THE STENT. THERE WERE STENT STRUT IMPRESSIONS ON THE SURFACE OF THE BALLOON, CENTERED BETWEEN THE MARKERBANDS. THERE WERE NO INDICATIONS OF PROFILE IRREGULARITIES OR ANY OTHER ANOMALIES THAT COULD CONTRIBUTE TO DISLODGEMENT OF THE STENT. THE BALLOON WAS TIGHTLY FOLDED, CONFIRMING THAT THE STENT DISLODGED WITHOUT POSITIVE (INFLATION) PRESSURE TO THE BALLOON. THERE WAS NO OTHER DAMAGE TO THE SDS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. THE 80% STENOSED, 2.25X12MM DENOVO TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND MODERATELY CALCIFIED SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY (RCA). THE DISTAL PORTION OF THE LESION WAS PREDILATED WITH A 2.0X9MM MAVERICK2 BALLOON AT 10ATMS FOR 9 SECONDS, FOLLOWED BY A 3.0X12MM MAVERICK2 BALLOON IN THE PROXIMAL LESION AT 14ATMS FOR 23 SECONDS AND A 2.5X15MM MAVERICK2 BALLOON IN THE DISTAL LESION AT 13ATMS FOR 32 SECONDS, LEAVING 40% RESIDUAL STENOSIS. A 2.25X20MM TAXUS LIBERTE ATOM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE SVG; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN ATTEMPTED TO ADVANCE THE SDS 3 TO 4 TIMES WITHOUT SUCCESS. ON THE FINAL ATTEMPT TO CROSS THE LESION THE DEVICE GOT HUNG UP ON A PREVIOUSLY IMPLANTED STENT AND THE TAXUS LIBERTE ATOM STENT DISLODGED FROM THE SDS. A 3.5X15MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO THE PROXIMAL LESION AND WAS INFLATED TO 12ATMS FOR 13 SECONDS, 9ATMS FOR 9 SECONDS AND 12ATMS FOR 9 SECONDS. A 3.0X18MM PROMUS SDS WAS THEN ADVANCED TO THE PROXIMAL LESION AND WAS DEPLOYED AT 9ATMS FOR 12 SECONDS AND 12ATMS FOR 11 SECONDS, CRUSHING THE DISLODGED STENT AGAINST THE VESSEL WALL. A 2.25X12MM TAXUS LIBERTE ATOM SDS WAS ADVANCED TO THE DISTAL PORTION OF THE LESION AND WAS SUCCESSFULLY DEPLOYED AT 9ATMS FOR 12 SECONDS AND 16ATMS FOR 11 SECONDS. A 3.0X15MM NC QUANTUM APEX BALLOON WAS THEN INFLATED IN THE PROXIMAL LESION AT 14ATMS FOR 14 SECONDS. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. THE 80% STENOSED, 2.25X12MM DENOVO TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND MODERATELY CALCIFIED SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY (RCA). THE DISTAL PORTION OF THE LESION WAS PREDILATED WITH A 2.0X9MM MAVERICK2 BALLOON AT 10 ATMS FOR 9 SECONDS, FOLLOWED BY A 3.0X12MM MAVERICK2 BALLOON IN THE PROXIMAL LESION AT 14 ATMS FOR 23 SECONDS AND A 2.5X15MM MAVERICK2 BALLOON IN THE DISTAL LESION AT 13 ATMS FOR 32 SECONDS, LEAVING 40% RESIDUAL STENOSIS. A 2.25X20MM TAXUS LIBERTE ATOM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE SVG; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN ATTEMPTED TO ADVANCE THE SDS 3 TO 4 TIMES WITHOUT SUCCESS. ON THE FINAL ATTEMPT TO CROSS THE LESION THE DEVICE GOT HUNG UP ON A PREVIOUSLY IMPLANTED STENT AND THE TAXUS LIBERTE ATOM STENT DISLODGED FROM THE SDS. A 3.5X15MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO THE PROXIMAL LESION AND WAS INFLATED TO 12 ATMS FOR 13 SECONDS, 9 ATMS FOR 9 SECONDS AND 12 ATMS FOR 9 SECONDS. A 3.0X18MM PROMUS SDS WAS THEN ADVANCED TO THE PROXIMAL LESION AND WAS DEPLOYED AT 9 ATMS FOR 12 SECONDS AND 12 ATMS FOR 11 SECONDS, CRUSHING THE DISLODGED STENT AGAINST THE VESSEL WALL. A 2.25X12MM TAXUS LIBERTE ATOM SDS WAS ADVANCED TO THE DISTAL PORTION OF THE LESION AND WAS SUCCESSFULLY DEPLOYED AT 9 ATMS FOR 12 SECONDS AND 16 ATMS FOR 11 SECONDS. A 3.0X15MM NC QUANTUM APEX BALLOON WAS THEN INFLATED IN THE PROXIMAL LESION AT 14 ATMS FOR 14 SECONDS. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) ATOM (TM) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620220 13956816

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 2.0X9MM MAVERICK2 BALLOON CATHETER| 2.5X15MM MAVERICK2 BALLOON CATHETER| 3.0X12MM MAVERICK2 BALLOON CATHETER