BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1834272 · Received September 14, 2010

    Report

    Report Number
    2134265-2010-04070
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME PATIENT AS MFR ID#: 2134265-2010-04069. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, BALLOON REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN AN UNKNOWN VESSEL. A 3.5X24MM VERIFLEX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, AND THE STENT WAS DEPLOYED AT 14ATM. WHILE REMOVING THE SDS BALLOON FROM THE DEPLOYED STENT, IT WAS REPORTED THAT THE BALLOON DID NOT EXTRACT EASILY. THE BALLOON WAS "STICKY". IT WAS REPORTED THAT A NON-BSC GUIDE WIRE, A NON BSC ASPIRATION CATHETER, A 2.0X20MM APEX BALLOON INFLATED TO 14ATM AND A 4.0X15MM QUANTUM BALLOON INFLATED TO 12ATM WERE ALSO USED DURING THIS PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE FOLLOWING DAY, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE FOR WHICH A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WAS TREATED. A 3.0X20MM VERIFLEX SDS WAS ADVANCED AND DEPLOYED AT 12ATM. WHILE REMOVING THE SDS BALLOON FROM THE DEPLOYED STENT, IT WAS REPORTED THAT THE BALLOON DID NOT EXTRACT EASILY. THE BALLOON WAS "STICKY". IT WAS REPORTED THAT A NON BSC GUIDE WIRE AND A 2.25X12MM APEX BALLOON INFLATED TO 10ATM WERE ALSO USED DURING THIS PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED AS AN EMERGENT CASE FOR THE FIRST PROCEDURE AND THE TARGET VESSEL WAS TREATED WITH THROMBECTOMY DUE TO THROMBOSIS PRIOR TO ANGIOPLASTY OR STENTING. AT THE FIRST PROCEDURE, THE DEVICES WERE USED IN THE FOLLOWING ORDER: A NON-BSC GUIDE WIRE FOLLOWED BY A NON-BSC THROMBECTOMY CATHETER. THE 2.0X20MM APEX WAS THEN USED FOR PREDILATION FOLLOWED BY DEPLOYMENT OF THE 3.5X24MM VERIFLEX. THE 4.0X15MM QUANTUM BALLOON WAS USED FOR POST DILATION. AT THE SECOND PROCEDURE DONE THE NEXT DAY, THE DEVICES WERE USED IN THE FOLLOWING ORDER: A 190CM NON-BSC GUIDE WIRE FOLLOWED BY THE 2.25X12MM APEX FOR PRE DILATION. THE 3.0X12MM VERIFLEX WAS THEN DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893420300 13558674

    Patients

    Seq Age Sex Outcome Treatment
    1