BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABRE VENOUS SELF-EXPANDING STENT SYSTEM

    MDR report key: 22150582 · Received June 5, 2025

    Report

    Report Number
    2183870-2025-00285
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    May 14, 2025
    Report Date
    August 15, 2025
    Manufacturer
    COVIDIEN
    Product Code
    QAN
    UDI-DI
    00643169796294
    PMA / PMN Number
    P200026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGE ANALYSIS IMAGE ONE IS OF THE SHIPPING CARTON. LOT NUMBER C062836 WAS OBSERVED ON THE LABEL ON THE SHIPPING CARTON AND IS CONSISTENT WITH THE LOT NUMBER PROVIDED IN GCH. IMAGE TWO IS OF THE DEVICE INSIDE A BAG. THE RED LOCKING PIN IS STILL IN PLACE; THE STENT IS OBSERVED TO BE DEPLOYED INSIDE THE SHEATH. IMAGE THREE IS A CINE IMAGE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS THE DEVICE RETURNED WITH THE RED LOCKING PIN STILL SECURELY IN THE HANDLE THE SIZE ON THE STRAIN RELIEF 9F 14MM X 18MM THE DISTAL SECTION OF THE CATHETER WAS LOADED IN AN UNKNOWN 9F INTRODUCER THE STENT WAS DEPLOYED BUT REMAINED FIXED TO THE INTRODUCER KINKS WERE OBSERVED ON THE INTRODUCER BIOLOGICS WERE OBSERVED ON THE SILVER ISOLATION SHEATH AND A KINK WAS NOTED ON THE SILVER SHEATH AND ON THE INNER TUBING BIOLOGICS WERE OBSERVED ON THE STENT AND THE STENT WAS DEFORMED . MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE ABRE SELF EXPANDING STENT ALONG WITH A 9FR NON-MEDTRONIC SHEATH, THE DEVICE WAS DEPLOYED IN THE LEFT DISTAL COMMON ILIAC VEIN (PERIPHERAL VEIN). THE ABRE STENT WAS PUT THROUGH 9FR SHEATH AND STENT WAS ALREADY DEPLOYING EVEN WITH SAFETY PIN IN PLACE. THE STENT DETACHED IN VIVO AND REQUIRED A SURGICAL CUT-DOWN INTERVENTION TO REMOVE THE DETACHED STENT. THE PATIENT'S COMMON FEMORAL VEIN TORE AFTER STENT DEPLOYED AND WAS REMOVED. THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND THE PROCEDURE WAS ABORTED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761754 ABRE VENOUS SELF-EXPANDING STENT SYSTEM STENT, ILIAC VEIN QAN COVIDIEN C062836 00643169796294

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Life Threatening| R| H