BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 1905135 · Received November 22, 2010

    Report

    Report Number
    9616290-2010-00018
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4) - IMPROPER OR INCORRECT PROCEDURE OR METHOD, INCORRECT REMOVAL. DIFFICULTY TO ADVANCE (PHYSICAL RESISTANCE) AND REMOVE AN UNEXPANDED STENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION, ACCESSORY DEVICE SUPPORT, OR INTERACTION WITH LESION OR ACCESSORY DEVICES. BASED ON THE REPORTED INFORMATION, THE REPORTED ADVANCEMENT DIFFICULTY APPEARS TO BE RELATED TO THE VERY CALCIFIED ANATOMY. DURING REMOVAL, INTERACTION BETWEEN THE CRIMPED STENT AND DISTAL TIP OF THE SHEATH MAY OCCUR AND CONTRIBUTE TO THE REPORTED REMOVAL RESISTANCE. IT SHOULD BE NOTED THAT THE OMNILINK ELITE INSTRUCTIONS FOR USE (IFU) INDICATE: DO NOT ATTEMPT TO PULL AN UNEXPANDED STENT BACK THROUGH THE INTRODUCER SHEATH; DISLODGEMENT OF THE STENT FROM THE BALLOON MAY OCCUR. DURING DEPLOYMENT OF THE STENT, IT WAS REPORTED THAT ONLY THE PROXIMAL SEGMENT OF THE STENT EXPANDED. PARTIAL DEPLOYMENT MAY BE INFLUENCED BY, BUT IS NOT LIMITED TO, STENT MOVEMENT, LEAKS/RUPTURES, PATIENT ANATOMICAL MORPHOLOGY (CALCIFICATION) INFLATION MEDIUM OR INFLATION TECHNIQUE. DURING MANUFACTURING, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR STENT DAMAGE AND PLACEMENT AS WELL AS SHAFT DAMAGE, AND A SAMPLING OF UNITS ARE DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE AND RATED BURST PRESSURE (RBP). THERE WAS NO REPORTED DAMAGE OR ISSUES PRIOR TO USE OR LEAKS/RUPTURES AFTER USE. INTERACTION WITH THE SHEATH TIP DURING THE REMOVAL ATTEMPT MAY HAVE CAUSED THE UNEXPANDED STENT TO MOVE ON THE BALLOON SUCH THAT THE DISTAL END OF THE STENT WAS NO LONGER ON THE BALLOON WORKING LENGTH, THUS CONTRIBUTING TO THE REPORTED UNEVEN DEPLOYMENT. ADDITIONAL NON-SURGICAL TREATMENT (BALLOON DILATATION CATHETER) WAS REQUIRED TO EXPAND THE DISTAL SEGMENT. THE REPORTED PHYSICAL RESISTANCE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT AND THE REPORTED DIFFICULT TO REMOVE AND DEPLOY APPEAR TO BE RELATED TO IMPROPER USER TECHNIQUE AND NOT A PRODUCT QUALITY DEFICIENCY. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION DILATION CATH: 4 X 100; SHEATH: 6F TERUMO; STENT: UNK 8 X 39 THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE STENT SYSTEM WAS ADVANCED WITH DIFFICULTY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT ILIAC ARTERY, RETROGRADE ACCESS, A NON-ABBOTT GUIDE WIRE WAS ADVANCED FOLLOWED BY THE OTW OMNILINK ELITE STENT SYSTEM. CONTRAST WAS INJECTED; HOWEVER, THE PHYSICIAN COULD NOT CLEARLY VISUALIZE; THEREFORE, AN ATTEMPT WAS MADE TO REMOVE THE STENT SYSTEM. THE STENT SYSTEM COULD NOT BE PULLED BACK INTO THE 6F INTRODUCER SHEATH SO ANOTHER ATTEMPT WAS MADE TO ADVANCE THE STENT SYSTEM TO THE LESION. THE STENT SYSTEM WAS ADVANCED SUCCESSFULLY TO THE LESION AND THE STENT WAS DEPLOYED; HOWEVER, ONLY THE PROXIMAL SEGMENT OF THE STENT EXPANDED. A DILATATION BALLOON WAS USED TO DEPLOY THE DISTAL SEGMENT OF THE STENT. THE STENT SYSTEM BALLOON WAS THEN INFLATED TO PERFORM POST DILATATION AND THE STENT WAS FULLY EXPANDED. A SECOND PLANNED UNSPECIFIED 8 X 39 STENT WAS SUCCESSFULLY DEPLOYED IN THE LEFT ILIAC ARTERY. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR CONCOMITANT MEDICAL PRODUCTS