BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 2872790 · Received December 13, 2012

    Report

    Report Number
    2024168-2012-07913
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 20, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCORRECT REMOVAL. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IT SHOULD BE NOTED THE OMNILINK ELITE VASCULAR BALLOON EXPANDABLE STENT SYSTEM INSTRUCTIONS FOR USE STATES: DO NOT ATTEMPT TO PULL AN UNEXPANDED STENT BACK THROUGH THE INTRODUCER SHEATH / GUIDING CATHETER; DISLODGEMENT OF THE STENT FROM THE BALLOON MAY OCCUR. SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. WHEN REMOVING THE DELIVERY SYSTEM AS A SINGLE UNIT, DO NOT RETRACT THE DELIVERY SYSTEM INTO THE INTRODUCER SHEATH/GUIDING CATHETER. POSITION THE PROXIMAL BALLOON MARKER JUST DISTAL TO THE TIP OF THE INTRODUCER SHEATH/GUIDING CATHETER. ADVANCE THE GUIDE WIRE IN THE ANATOMY AS FAR DISTALLY AS SAFELY POSSIBLE. SECURE THE DELIVERY SYSTEM TO THE INTRODUCER SHEATH/GUIDING CATHETER; THEN REMOVE THE INTRODUCER SHEATH/GUIDING CATHETER, GUIDE WIRE AND DELIVERY SYSTEM AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE COMMON ILIAC ARTERY, A 8X29X80 OTW OMNILINK ELITE PERIPHERAL STENT SYSTEM WAS ADVANCED THROUGH A 6F SHEATH AND SOME RESISTANCE WAS FELT; HOWEVER, THE PHYSICIAN DECIDED PRE-DILATATION NEEDED TO BE PERFORMED PRIOR TO ADVANCING THE STENT SYSTEM THROUGH THE TARGET LESION. WHILE WITHDRAWING THE STENT SYSTEM, THE STENT DISLODGED FROM THE BALLOON INSIDE OF THE PATIENT ANATOMY. REPORTEDLY, NO RESISTANCE WAS FELT AND NO FORCE WAS APPLIED TO THE STENT SYSTEM DURING WITHDRAWAL PRIOR TO THE STENT DISLODGEMENT. A SMALLER UNSPECIFIED BALLOON WAS ADVANCED AND INFLATED TO DEPLOY THE STENT IN THE EXTERNAL ILIAC ARTERY. ANOTHER STENT WAS SUCCESSFULLY DEPLOYED TO TREAT THE TARGET LESION IN THE COMMON ILIAC ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. 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 Other| R