BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA VXT

    MDR report key: 2963509 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00157
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    April 19, 2010
    Report Date
    June 3, 2010
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DYF
    PMA / PMN Number
    K992958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO GRAFT SEGMENTS WERE RETURNED IN SEALED CONTAINERS SUBMERGED IN LIQUID, PRESUMABLY FORMALIN. EACH CONTAINER WAS LABELED WITH THE LOT NUMBER OF THE GRAFT. LOT # 0450603R WAS APPROX. 3 CM IN LENGTH, AND HAD VISIBLE SUTURES ON ONE END, PRESUMABLY WHERE THE GRAFT WAS SUTURED TO THE ARTERY. A SIGNIFICANT AMOUNT OF TISSUE WAS OBSERVED ON THE ADVENTITIAL SURFACE OF THE SAMPLE. NO OBVIOUS DEFECTS OR CLAMP MARKS WERE SEEN, ALTHOUGH THE TISSUE MAY HAVE COVERED A CLAMP MARK THAT MAY HAVE OCCURRED DURING IMPLANTATION. LOT # AH0770230R WAS APPROX. 1.5CM IN LENGTH. SUTURES AND A CLAMP MARKS CAN BE SEEN WHERE THIS GRAFT SEGMENT WAS ATTACHED TO THE PREVIOUS GRAFT. NO ADVENTITIAL TISSUE WAS SEEN ON THIS GRAFT SEGMENT. THE QC RECORDS FOR BOTH LOTS OF GRAFT MATERIAL WERE REVIEWED AND NO ABNORMALITIES WERE SEEN. ALL RECORDS, DATA AND OBSERVATIONS INDICATE THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    ATRIUM MEDICAL CORP RECEIVED A COMPLAINT OF SEROMA FORMATION FROM A CUSTOMER OF ST. JUDE MEDICAL, (B)(4). THE SURGEON CREATED A STRAIGHT-LINE SHUNT IN A PATIENT WITH A PREVIOUS ATRIUM GRAFT WHOSE SHUNT HAD CLOSED, ACCORDING TO THE E-MAIL RECEIVED FROM ST. JUDE. A 5MM SW ADVANTA VXT W/ GDS (LOT # AH0450603R) WAS USED TO CREATE A SHUNT FROM THE BRACHIAL ARTERY TO THE CEPHALIC VEIN ON (B)(6) 2010. ACCORDING TO THE NOTES, A SEROMA OCCURRED APPROX. 2CM FROM THE ARTERY, AND THE SURGEON DECIDED TO REPLACE THE GRAFT PARTIALLY WITH A SEGMENT OF ANOTHER 5MM SW ADVANTA VXT (LOT# AH0770230R) ON (B)(6) 2010. A SIMILAR SEROMA APPEARED IN THIS SEGMENT AS WELL. ACCORDING TO THE E-MAIL, ¿ THE PHYSICIAN ATTEMPTED TO STOP THE SEROMA BY USING ADHESIVE, STYPTIC, AND COTTON, BUT FAILED.¿ THE GRAFT WAS REMOVED ON (B)(6) 2010 AND A SHUNT WAS CREATED ON THE OPPOSITE SIDE WITH NATIVE VESSEL. THE EXPLANTS WERE SENT TO ATRIUM TO BE ANALYZED TO DETERMINE THE CAUSE OF THE SEROMA FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668 ADVANTA VXT DYF ATRIUM MEDICAL CORP. 22011 AH04506; AH07702

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 7-0 PROLINE