BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3222197 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-04938
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

      DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT WAS DAMAGED AT THE PROXIMAL END. VARIOUS STRUTS ON THE MOST PROXIMAL ROWS WERE LIFTED AND MISALIGNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. NO ISSUES WERE NOTED WITH THE TIP AND BALLOON OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 90% STENOSED, ECCENTRIC, DE NOVO WITH 32 MM LONG AND 2.75 MM VESSEL DIAMETER TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PREDILATED WITH AN UNSPECIFIED DEVICE WHICH REDUCED THE STENOSIS TO 40%. A 32 X 2.25MM TAXUS LIBERTÉ DRUG-ELUTING STENT ENCOUNTERED RESISTANCE DURING ADVANCING AND WAS NOT ABLE TO CROSS IN THE TARGET LESION. THE STENT WAS NOTED TO BE DEFORMED AND NOT FLEXIBLE WITH BAD PROFILE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 90% STENOSED, ECCENTRIC, DE NOVO WITH 32 MM LONG AND 2.75 MM VESSEL DIAMETER TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PREDILATED WITH AN UNSPECIFIED DEVICE WHICH REDUCED THE STENOSIS TO 40%. A 32 X 2.25MM TAXUS¿ LIBERTÉ¿ DRUG-ELUTING STENT ENCOUNTERED RESISTANCE DURING ADVANCING AND WAS NOT ABLE TO CROSS IN THE TARGET LESION. THE STENT WAS NOTED TO BE DEFORMED AND NOT FLEXIBLE WITH BAD PROFILE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322567 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894032220 15906252

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR