BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENOVO VENOUS STENT

    MDR report key: 25147224 · Received May 12, 2026

    Report

    Report Number
    9681442-2026-00097
    Event Type
    Death
    Date Received
    May 12, 2026
    Date of Event
    April 20, 2026
    Report Date
    April 26, 2026
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    QAN
    UDI-DI
    00801741103308
    PMA / PMN Number
    P180037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW UP REPORT WILL BE SUBMITTED AS APPLICABLE. SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A VENOPLASTY WITH STENTING PROCEDURE USING VENOVO VENOUS STENTS VIA BILATERAL BRACHIAL ACCESS AFTER THROMBECTOMY WITH PENUMBRA. IT WAS REPORTED THAT PRIOR TO PLACING THE STENTS THE PATIENT HAD ALREADY UNDERGONE VENOPLASTY WITH TWELVE MM BALLOONS SIMULTANEOUSLY. THE STENTS WERE THEN PLACED AND POST DILATED WITH THE SAME TWELVE MM BALLOONS. IT WAS NOTED THAT STENT WAS ACCURATELY PLACED WITHOUT ISSUE. HOWEVER, AFTER POST DILATION, THE PATIENT BECAME HYPOTENSIVE. A VENOGRAM WAS PERFORMED AND NO ISSUES WERE REPORTEDLY FOUND WITH THE STENT PLACEMENT. ATTEMPTS WERE MADE TO SUSTAIN THE PATIENT'S BLOOD PRESSURE BUT WERE UNSUCCESSFUL. THE PATIENT REPORTEDLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208028 VENOVO VENOUS STENT VENOUS STENT QAN ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNKNOWN 00801741103308

    Patients

    Seq Age Sex Outcome Treatment
    1