BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1811749 · Received August 23, 2010

    Report

    Report Number
    2134265-2010-03786
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE MIDSHAFT WAS STRETCHED AND KINKED. AN EXAMINATION OF THE BALLOON FOUND THAT THE BALLOON WAS NOT REFOLDED. AN EXAMINATION OF THE PROXIMAL WELD REGION FOUND NO ANOMALIES. DUE TO THE DAMAGE TO THE MIDSHAFT IT WAS NOT POSSIBLE TO INFLATE THE BALLOON. 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 FURTHER RECORDED THAT THE TARGET LESION WAS DE NOVO, 35MM LONG, CONCENTRIC AND 60-70% STENOSED AND THAT THE VESSEL WAS NOT TOTALLY OCCLUDED. THERE WAS MILD TO MODERATE CALCIFICATION OF THE VESSEL AT THE PROXIMAL AND DISTAL SEGMENTS. IT WAS SEVERELY TORTUOUS MAINLY IN THE PROXIMAL AND MIDDLE SEGMENTS. THERE WAS NO SIGNIFICANT LESION BEND. THE LOCATION OF THE LIBERTE STENT WAS CHANGED TO DISTAL RCA - WAS ORIGINALLY REPORTED TO BE MID RCA. THE LESION WAS PREDILATED AS IT WAS A "FAIRLY TIGHT LESION" THAT REQUIRED VESSEL PREPARATION. THE STENT WAS DEPLOYED AT 16ATM FOR 29 SECONDS. AN ATTEMPT WAS MADE TO FULLY DEFLATE THE STENT DELIVERY SYSTEM (SDS) BALLOON, BUT THE BALLOON SEEMED TO REMAIN A LITTLE INFLATED. IT WAS NOT FULLY DEFLATED WHEN IT WAS REMOVED. ONCE OUT OF THE PATIENT, NO DAMAGE WAS NOTED ON THE BALLOON, BUT THE STENT DELIVERY SYSTEM WAS STRETCHED AND THINNED OUT. A 5.0X15MM NON-BSC BALLOON CATHETER WAS ADVANCED FOR POST DILATION RESULTING IN "GOOD AND MINIMAL" STENOSIS. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT WAS STABLE POST PROCEDURE AND WAS "DISCHARGED ACCORDINGLY".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, BALLOON WITHDRAWAL RESISTANCE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). A 5.0X24MM LIBERTE BARE MONORAIL STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND SUCCESSFULLY DEPLOYED IN THE TARGET LESION. THE SDS BALLOON WAS DEFLATED AND WHILE ATTEMPTING TO REMOVE IT, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN CHECKED TO MAKE SURE THE BALLOON WAS FULLY DEFLATED AND ATTEMPTED TO WITHDRAW AGAIN, BUT RESISTANCE WAS STILL FELT. THE PHYSICIAN PULLED ON THE PROXIMAL SHAFT WITH A SLOW AND STEADY PRESSURE "FOR SOME TIME", AND THE SDS EVENTUALLY CAME LOOSE AND WAS ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893824500 13243402

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR