BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 2122223 · Received June 13, 2011

    Report

    Report Number
    2024168-2011-04141
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: TERUMO 0.35. INFLATION: ABBOTT. SHEATH: TERUMO 6F. STENT: OMNILINK ELITE. BASED ON THE REPORTED INFORMATION, THE STENT DISLODGEMENT OR STENT MOVEMENT APPEARS TO BE RELATED TO INTERACTION WITH THE PREVIOUSLY PLACED STENT. BECAUSE IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO ADVANCE THE 7.0 X 39 X 80 OMNILINK ELITE STENT SYSTEM THROUGH THE PREVIOUSLY PLACED STENT IN THE LEFT ILIAC ARTERY CAUSING THE STENT TO DISLODGE, IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTIONS FOR USE STATES: WHEN TREATING MULTIPLE LESIONS, THE DISTAL LESION SHOULD BE INITIALLY STENTED, FOLLOWED BY STENTING OF THE PROXIMAL LESION. STENTING IN THIS ORDER OBVIATES THE NEED TO CROSS THE PROXIMAL STENT IN PLACEMENT OF THE DISTAL STENT AND REDUCES THE CHANCES FOR DISLODGING THE STENT. IN THIS CASE, THE REPORTED DIFFICULTY AND STENT MOVEMENT APPEARS TO BE RELATED TO THE ATTEMPT TO CROSS A PREVIOUSLY PLACED STENT. THE INABILITY TO CROSS CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE DIFFICULTY CROSSING APPEARS TO BE RELATED TO INTERACTION WITH THE PREVIOUSLY PLACED STENT. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO USE ERROR OF STENTING DISTAL TO A PREVIOUS PLACED STENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, VIA CROSS OVER APPROACH, TWO OMNILINK ELITE STENTS WERE IMPLANTED SUCCESSFULLY; ONE IN THE LEFT ILIAC ARTERY AND ONE IN THE LEFT EXTERNAL ILIAC ARTERY. AN ATTEMPT WAS MADE TO ADVANCE A 7.0X39X80 OMNILINK ELITE STENT SYSTEM THROUGH THE PREVIOUSLY PLACED STENT IN THE LEFT ILIAC ARTERY; HOWEVER, THE STENT BECAME CAUGHT ON THE PROXIMAL END OF THE PREVIOUSLY DEPLOYED STENT AND PARTIALLY DISLODGED FROM THE BALLOON. THE PROXIMAL SEGMENT OF THE STENT REMAINED ON THE BALLOON. THE PHYSICIAN WAS ABLE TO FULLY DEPLOY THE STENT IN THE ILIAC ARTERY. IMAGES REVEALED THAT THE ARTERY WAS OCCLUDED AND ISCHEMIA OCCURRED. SURGICAL INTERVENTION WAS REQUIRED TO PERFORM A FEMORAL BYPASS. REPORTEDLY, THE CONDITION OF THE PATIENT IS GOOD. 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 657863

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention