BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENATECH LP

    MDR report key: 9625664 · Received January 24, 2020

    Report

    Report Number
    9612452-2020-00004
    Event Type
    Injury
    Date Received
    January 24, 2020
    Date of Event
    December 20, 2019
    Report Date
    January 23, 2020
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    DTK
    UDI-DI
    04038653917051
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: PRODUCT REFERENCE 4435125 IS NOT CLEARED FOR SALES IN THE USA, BUT IT IS SIMILAR TO THE PRODUCT REFERENCE 5010025 CLEARED UNDER #510K010485. BATCH HISTORY REVIEW: A REVIEW OF THE MANUFACTURING RECORDS SHOWS THIS BATCH OF FILTERS COMPLIED WITH SPECIFICATIONS. NO OTHER SIMILAR COMPLAINTS WERE REPORTED TO THE MANUFACTURER FOR THIS LOT OF VENA CAVA FILTERS, SOLD SINCE OCTOBER 2018. INVESTIGATION: THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE X-RAY PICTURE SENT TO US SHOWS THAT THE FILTER IS TOTALLY CLOSED ALONG THE VESSEL WALL. CONCLUSION: NO THOROUGH INVESTIGATION IS POSSIBLE AND THE EXACT CAUSE OF WHAT HELD THE FILTER CLOSED CANNOT BE FOUND. HOWEVER THE FACT THAT THE FILTER DID NOT MOVE AFTER DEPLOYMENT, SEEMS SHOWING THAT THE IVC WALL WAS DISSECTED DURING THE IMPLANTATION PROCEDURE PREVENTING THE CORRECT DEPLOYMENT OF THE FILTER. THIS CAN HAPPEN IN PARTICULAR IF THE FILTER IS PUSHED TO BE RELEASE INSTEAD OF THE SHEATH BEING WITHDRAWN. THE IFU SPECIFIES THAT IT IS IMPORTANT NOT TO MOVE THE PUSHER DURING RELEASE TO ASSURE GOOD FILTER POSITION. THIS TYPE OF INCIDENT IS A KNOW COMPLICATION OF THE VENA CAVA FILTER IMPLANTATIONS. THE COMPLAINT RATE FOR THIS TYPE OF INCIDENT ON VENATECH LP IS LOW. NO CORRECTIVE ACTION IS ENVISAGED.

    Description of Event or Problem · 1

    "ACCORDING THE CUSTOMER: POSITIONING WAS MADE, THE SHEATH WAS PLACED AND THE FILTER WAS PUSHED INTO THE INFERIOR VENA CAVA. THE FILTER DID NOT OPEN. IT STUCK TO THE WALL OF THE INFERIOR VENA CAVA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92394 VENATECH LP VENA CAVA FILTER SYSTEM DTK B.BRAUN MEDICAL SAS 4435125 36937584 04038653917051

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention