BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 13978528 · Received April 1, 2022

    Report

    Report Number
    2024168-2022-03474
    Event Type
    Injury
    Date Received
    April 1, 2022
    Date of Event
    March 9, 2022
    Report Date
    July 15, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIO
    UDI-DI
    08717648178542
    PMA / PMN Number
    P110043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL OMNILINK STENT DELIVERY SYSTEM (SDS) (1012632-39, 1050441) IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES AND SUBSEQUENT SURGICAL INTERVENTION APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. ATTACHMENT: USER FACILITY MEDWATCH REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY. DURING ADVANCING OF THE FIRST OMNILINK STENT DELIVERY SYSTEM (SDS) (1012632-39, 1050441), THE STENT DISLODGED, AND A SNARE DEVICE WAS USED TO RETRIEVE THE DISLODGED STENT SUCCESSFULLY. A SECOND OMNILINK SDS (1012632-29, 1030941) WAS ADVANCED INTO THE VESSEL AND THE STENT DISLODGED AS WELL. THE DISLODGED STENT WAS ABLE TO BE RETRIEVED WITH THE DELIVERY SYSTEM BUT A CUT DOWN OF THE VESSEL WAS PERFORMED TO REMOVE THE SECOND DISLODGED STENT. THERE WAS SOME RESISTANCE NOTED DURING ADVANCEMENT DUE TO A SHARP ANGLE IN THE VESSEL. A THIRD OMNILINK SDS WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MEDWATCH REPORT RECEIVED STATES, STENT CAME OFF OF STENT BALLOON IN THE RIGHT COMMON ILIAC ARTERY AND WAS PARTIALLY REMOVED USING BALLOON TRAPPING, BUT WAS UNABLE TO BE REMOVED FROM THE LEFT FEMORAL ARTERIOTOMY SITE REQUIRING SURGICAL EXPLORATION AND FOREIGN BODY EXTRACTION FOLLOWED BY DIRECT REPAIR OF THE LEFT FEMORAL ARTERIOTOMY SITE WITH PROBABLE PERIOPERATIVE BLOOD LOSS ANEMIA. PER THE PHYSICIAN, THERE WAS NO BLEEDING COMPLICATION DURING THE PROCEDURE AND NO INTERVENTION PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328303 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT DELIVERY SYSTEM NIO ABBOTT VASCULAR 1012632-29 1030941 08717648178542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention