BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCU-GUARD PERIPHERAL VASCULAR PATCH

    MDR report key: 2051395 · Received April 7, 2011

    Report

    Report Number
    2183620-2011-00028
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 9, 2011
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DXZ
    PMA / PMN Number
    K983602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SYNOVIS' VASCU-GUARD PRODUCT IS MANUFACTURED IN A CONTROLLED ENVIRONMENT UNDER STRICT CONTROLS. ALL VASCU-GUARD PRODUCTS MUST UNDERGO 100% STERILITY VERIFICATION AS PART OF OUR MANUFACTURING PROCESS. IN ADDITION, OUR CHEMICAL STERILANT IS VALIDATED AS EFFECTIVE AGAINST STAPHYLOCOCCUS AUREUS. THE DEVICE HISTORY RECORD WAS REVIEWED. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICE PASSED STERILITY VERIFICATION AND MET SPECIFICATION AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED AN IMPLANT OF A 01X08 VASCU-GUARD PATCH FOR REPAIR OF THE RIGHT CAROTID ARTERY. THE PT WAS REPORTED TO BE AN ASA 4 AND IN DECLINING HEALTH. IT WAS NOTED THAT THE IMPLANT PROCEDURE WENT WELL AND WITHOUT COMPLICATION. THE PHYSICIAN REPORTED THAT HE USES METICULOUS ASEPTIC TECHNIQUE, INCLUDING GLOVE CHANGE, PRIOR TO HANDLING IMPLANTABLE DEVICES. APPROX 12 DAYS POST-PROCEDURE, THE PT PRESENTED WITH A NECK ABSCESS AND WAS TAKEN TO THE OPERATING ROOM FOR INCISION AND DRAINAGE OF THE NECK ABSCESS. CULTURES OF THE AREA WERE TAKEN AND PATHOLOGICAL ANALYSIS REVEALED MRSA. THE PT WAS PRESCRIBED AN UNSPECIFIED ANTIBIOTIC. INFECTION CONTROL AT THE USER FACILITY WAS NOTIFIED. IT WAS REPORTED THAT THE PT CURRENTLY WORKS IN A NURSING HOME AND IS MOST LIKELY EXPOSED TO MRSA AS A HEALTHCARE WORKER. THE PT'S CURRENT STATUS IS UNK. IT WAS FURTHER NOTED THAT THE PT WAS SCREENED FOR MRSA PRIOR TO THE IMPLANT PROCEDURE AND TEST RESULTS WERE NEGATIVE FOR MRSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCU-GUARD PERIPHERAL VASCULAR PATCH VASCULAR PATCH DXZ SYNOVIS SURGICAL INNOVATIONS VG 0108 5774147-1413206

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other