BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM

    MDR report key: 3191453 · Received June 26, 2013

    Report

    Report Number
    2024168-2013-04004
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - USE AFTER DAMAGE. THE DEVICE WAS RETURNED FOR ANALYSIS. THE FAILURE TO DEPLOY WAS ABLE TO BE CONFIRMED. THE KINK WAS UNABLE TO BE CONFIRMED; HOWEVER, THE OUTER MEMBER WAS SEPARATED WHICH WAS LIKELY THE INITIAL LOCATION OF THE KINK. THE DEVICE OPERATING DIFFERENTLY COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE ABSOLUTE PRO LL SELF EXPANDING STENT SYSTEM INSTRUCTIONS FOR USE STATES: REMOVE THE HANDLE FROM THE PACKAGE AND THE SHAFT FROM THE HOOP. LAY THE DEVICE FLAT AND MINIMIZE EXCESSIVE HANDLING. THE SHAFT MAY KINK IF NOT HANDLED CAREFULLY. DO NOT USE IF SHAFT IS KINKED. IN THIS CASE, IT IS LIKELY THAT THE SHAFT WAS INADVERTENTLY HANDLED DURING PREPARATION SUCH THAT THE ATTEMPTS TO STRAIGHTEN THE SHAFT MAY HAVE CONTRIBUTED TO THE OUTER MEMBER WEAKENING AND SUBSEQUENTLY SEPARATING, WHICH IN TURN WOULD HAVE CONTRIBUTED TO THE INABILITY TO DEPLOY THE STENT. FURTHERMORE, THE CLICKING NOISE WAS LIKELY THE INNER GEARS OF THE HANDLE INTERACTING AS DUE TO THE OUTER MEMBER SEPARATION, THE INTERNAL MECHANISMS WOULD NOT BE ABLE TO DEPLOY THE STENT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKAGING OF THE 5.0X150 ABSOLUTE PRO LL STENT DELIVERY SYSTEM, THE CATHETER KINKED AT RIGHT ANGLES AT THE JUNCTION OF THE HANDLE AND THE CATHETER. THE PHYSICIAN BENT THE CATHETER TO THE ORIGINAL POSITION AND IT APPEARED TO BE FINE. THE DEVICE WAS ADVANCED THROUGH THE SHEATH TO THE TARGET SITE. WHEN AN ATTEMPT WAS MADE TO TURN THE THUMBWHEEL TO DEPLOY THE STENT, AN ABNORMAL CLICKING NOISE WAS HEARD AND THE STENT DID NOT DEPLOY. THE STENT DELIVERY SYSTEM WAS WITHDRAWN FROM THE ANATOMY. THERE WAS NO EXPOSURE OF THE STENT. THE DEVICE WAS REPLACED WITH ANOTHER UNSPECIFIED DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED THAT THE OUTER MEMBER WAS TORN AT THE DISTAL END OF THE STRAIN RELIEF TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290024 ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 1050251

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR SHEATH: TERUMO ADVANCE