BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ (TM)

    MDR report key: 2191995 · Received August 4, 2011

    Report

    Report Number
    2134265-2011-03219
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. AN EXAMINATION OF THE RETURNED DEVICE FOUND A BREAK IN THE HYPOTUBE AT 59.3CM DISTAL TO STRAIN RELIEF. A SEVERE KINK WAS EVIDENT IN THE HYPOTUBE AT 57CM DISTAL TO THE STRAIN RELIEF. A MICROSCOPIC EXAMINATION OF THE BREAK SITE IDENTIFIED THAT THE BREAK OCCURRED AS A RESULT OF A SEVERE KINK THAT OCCURRED IN THE HYPOTUBE. A SEVERE KINK WAS PRESENT IN THE MIDSHAFT AT 2.7CM PROXIMAL TO THE PORT SITE. NO ISSUES WERE NOTED WITH THE PROFILES OF THE CRIMPED STENT, BALLOON AND TIP SECTIONS OF THIS 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ANGIOPLASTY TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 70% STENOSED, ECCENTRIC SHAPED, DE-NOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT CORONARY ARTERY. THE LESION WAS NOT PRE-DILATED. A 24 X 3.00MM MODEL-LIBERTE BARE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO LESION WITHOUT RESISTANCE; HOWEVER, BEFORE IMPLANTING THE STENT THE SHAFT OF THE SDS BROKE IN HALF. THE BROKEN SDS WAS WITHDRAWN FROM THE PATIENT BY A "CONVENTIONAL PROCESS" WITHOUT COMPLICATIONS AND THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ANGIOPLASTY TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 70% STENOSED, ECCENTRIC SHAPED, DE-NOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT CORONARY ARTERY. THE LESION WAS NOT PRE-DILATED. A 24 X 3.00MM MODEL-LIBERTE BARE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO LESION WITHOUT RESISTANCE; HOWEVER, BEFORE IMPLANTING THE STENT THE SHAFT OF THE SDS BROKE IN HALF. THE BROKEN SDS WAS WITHDRAWN FROM THE PATIENT BY A "CONVENTIONAL PROCESS" WITHOUT COMPLICATIONS AND THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTÉ (TM) STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893824300 13752050

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR GUIDE CATHETER: 6FR 4.0FR