BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1911996 · Received December 1, 2010

    Report

    Report Number
    2134265-2010-05335
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE STENT DELIVERY SYSTEM WAS RETURNED WITH NO STENT OR SNARE. BLOOD AND CONTRAST WAS VISIBLE IN THE DISTAL AND MIDSHAFT OF THE DEVICE WHICH IS CONSISTENT WITH THE DEVICE BEING USED. THE RETURNED CATHETER WAS VISUALLY, TACTILELY EXAMINED ALONG THE ENTIRE LENGTH AND NO DAMAGE WAS FOUND. THE DISTAL END WAS FURTHER INSPECTED UNDER MAGNIFICATION AND IT WAS DETERMINED THAT THE STENT WAS NO LONGER PRESENT ON THE STENT DELIVERY SYSTEM. THERE WERE STENT STRUT IMPRESSIONS PRESENT ON THE SURFACE OF THE BALLOON BETWEEN THE MARKER BANDS, INDICATING THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. THE BALLOON WAS IN A TIGHTLY FOLDED CONDITION, AS-RECEIVED, AND MICROSCOPIC EXAMINATION OF THE BALLOON PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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 ARTERY TREATMENT PROCEDURE THE STENT DISLODGED. THE LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A 4.0X16MM VERIFLEX STENT IN THE LESION AND WITHOUT BEING INFLATED THE STENT CAME OFF THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED BY USING ANOTHER VERIFLEX 4.0X24MM TO SECURE THE 4.0X16MM STENT IN THE PROX RIGHT CORONARY ARTERY. THE PATIENT STATUS IS LISTED AS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE THE STENT DISLODGED. THE LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A 4.0X16MM VERIFLEX STENT IN THE LESION AND WITHOUT BEING INFLATED THE STENT CAME OFF THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED BY USING ANOTHER VERIFLEX 4.0X24MM TO SECURE THE 4.0X16MM STENT IN THE PROX RIGHT CORONARY ARTERY. THE PATIENT STATUS IS LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893516400 13352842

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention 7 FR JR 4 GUIDE CATHETER| PROWATER GUIDEWIRE| ABBOTT GRAND SLAM GUIDEWIRE| 4.0X24MM VERIFLEX STENT| CORDIS 7 FR GUIDE CATHETER| 3.5X20MM MAVERICK BALLOON| 3.5XX12MM DRIVER STENT| 2.9 JOVUS EAGLE EYE IVUS CATHETER