BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2040291 · Received April 5, 2011

    Report

    Report Number
    2134265-2011-00924
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED NO DAMAGE TO THE SHAFT. AN EXAMINATION OF THE CRIMPED STENT FOUND THAT THE DISTAL EDGE OF STENT WAS FLARED. THERE WAS NO EVIDENCE TO SUGGEST THAT THE BALLOON HAD BEEN INFLATED. NO OTHER DAMAGE WAS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED LEFT MAIN ARTERY (LM). THE PHYSICIAN ATTEMPTED TO INSERT A 4.00X12MM LIBERTE BARE STENT DELIVERY SYSTEM (SDS); HOWEVER, BEFORE INSERTION IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. THE DEVICE DID NOT ENTER THE PATIENT AND A LIBERTE BARE STENT WAS DEPLOYED IN THE LESION AT 16ATMS, FOLLOWED BY POSTDILATION WITH A 5.0X8MM NON BSC BALLOON AT 20ATMS. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED LEFT MAIN ARTERY (LM). THE PHYSICIAN ATTEMPTED TO INSERT A 4.00X12MM LIBERTE BARE STENT DELIVERY SYSTEM (SDS); HOWEVER, BEFORE INSERTION IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. THE DEVICE DID NOT ENTER THE PATIENT AND A LIBERTE BARE STENT WAS DEPLOYED IN THE LESION AT 16ATMS, FOLLOWED BY POSTDILATION WITH A 5.0X8MM NON BSC BALLOON AT 20ATMS. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893812400 13411154

    Patients

    Seq Age Sex Outcome Treatment
    1