BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCU-GUARD

    MDR report key: 12134537 · Received July 8, 2021

    Report

    Report Number
    1416980-2021-04161
    Event Type
    Injury
    Date Received
    July 8, 2021
    Report Date
    August 9, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    DXZ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDRESS: (B)(6). LITERATURE ARTICLE: JARA M., MALINOWSKI M., BAHRA M., STOCKMANNN M., SCHULZ A., PRATSCHKE J., AND PUHL G. "BOVINE PERICARDIUM FOR PORTAL VEIN RECONSTRUCTION IN ABDOMINAL SURGERY: A SURGICAL GUIDE AND FIRST EXPERIENCES IN A SINGLE CENTER". DIG SURG 2015; 32:135¿141. DOI: 10.1159/000370008. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED SEGMENTAL STENOSIS OF THE MAIN TRUNK OF THE PORTAL VEIN AFTER UNDERGOING A PANCREATIC SURGERY WITH VENOUS RECONSTRUCTION IN WHICH A VASCU-GUARD PATCH WAS USED. THE CAUSE OF THE EVENT WAS NOT REPORTED. IT WAS REPORTED THAT FOLLOWING EN BLOC RESECTION OF THE TUMOR AND INVOLVED VEIN, THE PROXIMAL AND DISTAL PORTION OF THE PORTAL VEIN (PV) WAS CLAMPED. THE ADAPTED VASCU-GUARD WAS FIXED TO THE PROXIMAL AND DISTAL END OF THE PV WITH CORNER STITCHES. CONTINUOUS AND UNLOCKED STITCHES WERE USED. TREATMENT OR INTERVENTION FOR THE EVENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032286 VASCU-GUARD PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other