BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCU-GUARD

    MDR report key: 161028 · Received March 30, 1998

    Report

    Report Number
    2183620-1998-00007
    Event Type
    Injury
    Date Received
    March 30, 1998
    Date of Event
    March 2, 1998
    Report Date
    March 30, 1998
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    DXZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOSP INFORMED BIO-VASCULAR, INC. THAT ON 3/2/1998 THE SURGEON PERFORMED A CAROTID PATCH ENDARTERECTOMY USING A BIO-VASCULAR VASCU-GUARD PATCH. THIS PT WAS PART OF A CAROTID PATCH STUDY AT THE HOSP. 45 MINUTES AFTER COMPLETION OF THE PROCEDURE, THE PT WAS FOUND TO HAVE LEFT SIDED HEMIPARESIS. THE PT WAS TAKEN BACK TO THE OPERATING ROOM IMMEDIATELY BECAUSE THE ARTERY WAS OCCLUDED. THE VASCU-GUARD PATCH WAS REMOVED AND REPLACED WITH SAPHENOUS VEIN. THE SURGEON COMMENTED THAT THERE IS A POSSIBLE RELATIONSHIP BETWEEN THE COMPLICATION AND THE USE OF THE VASCU-GUARD PATCH, ALTHOUGH NOT DEFINITIVE. THE PT DID HAVE AN OCCLUSION PREVIOUSLY AFTER A FEMORAL-FEMORAL BYPASS. ONE OF THE OTHER DOCTORS WHO IS WORKING ON THIS STUDY COMMENTED THAT HE DOUBTS THAT THIS INCIDENT IS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCU-GUARD Implant VASCULAR TISSUE PATCH DXZ BIO-VASCULAR, INC. VG-0106 VGS-97H21-078

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention