BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEALPTFE

    MDR report key: 1833921 · Received September 9, 2010

    Report

    Report Number
    9612515-2010-00006
    Event Type
    Other
    Date Received
    September 9, 2010
    Date of Event
    May 19, 2010
    Report Date
    September 10, 2010
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: AS OF (B)(6) 2010, THE GRAFT HAS NOT BEEN EXPLANTED. VASCUTEK WOULD EXPECT THE GRAFT TO BE RETURNED FOR INVESTIGATION WHEN EXPLANTED. RESULTS: REVIEW OF MANUFACTURING & QC RECORDS. THE MANUFACTURING AND QC RECORDS FOR THE BATCH HAVE BEEN REVIEWED AND THERE IS NOTHING TO SUGGEST A PROBLEM WITH THE BATCH. THE GRAFT IN QUESTION WAS CONTAINED IN A BATCH OF 57 UNITS WHICH WERE DISPATCHED BETWEEN (B)(6) 2010. THIS TYPE OF SWELLING, DUE TO SEROMA FORMATION, IS A KNOWN COMPLICATION WITH EPTFE VASCULAR PROSTHESIS. THE INCIDENCE OF SEROMA IS HIGHER IN EXTRA-ANATOMIC GRAFTS THAN CONVENTIONAL ABDOMINAL IMPLANTS. (B)(6) REPORTS OF A SURVEY OF 279 CASES WHERE PERIGRAFT SEROMAS WERE IDENTIFIED. FIFTY-FOUR PERCENT OF CASES INVOLVED KNITTED DACRON AND 34% INVOLVED PTFE. HE STATES THAT GRAFT REPLACEMENT PROVIDED A 92% CURE RATE. THE ASSOCIATION OF SEROMA WITH IMPLANT LOCATION RATHER THAN THE GRAFT TYPE WAS ALSO SHOWN BY (B)(6). FOUR PERCENT OF THE SEROMAS HE DESCRIBED WERE WITH AXILLOAXILLARY GRAFTS.

    Description of Event or Problem · 1

    THE EVENT OCCURRED AT (B)(6) IN (B)(6), USA. PATIENT HAS END STAGE RENAL DISEASE AND UNDERWENT CREATION OF AN ARTERIOVENOUS FISTULA WITH NONAUTOGENOUS GRAFT ON (B)(6) 2010. THE ARTERIAL INFLOW WAS FROM THE PROXIMAL BRACHIAL ARTERY AND THE VENOUS OUTFLOW WAS THE CENTRAL BRACHIAL VEIN. FOLLOWING THE PROCEDURE HE EXPERIENCED PROGRESSIVELY ENLARGING SEROMA AROUND THE GRAFT. UNTIL BY (B)(6) 2010 IT WAS CONTINUING TO ENLARGE AND MEASURED 6.3 X 4.5 CM BY ULTRASOUND. REMOVAL OF THE GRAFT WAS RECOMMENDED BUT HAS NOT YET BEEN DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEALPTFE VASCULAR PROSTHESIS DSY VASCUTEK LTD. UNKNOWN P2358/3B 2031

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R