BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANTA PTFE VS GRAFT

    MDR report key: 2963898 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00228
    Event Type
    Other
    Date Received
    January 2, 2013
    Date of Event
    July 10, 2012
    Report Date
    July 10, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DYF
    PMA / PMN Number
    K992441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED GRAFT SAMPLE WAS TAKEN OUT OF THE VIAL AND VISUALLY EXAMINED IN A BIO-HOOD. THE SAMPLE WAS COMPLETELY COVERED WITH BIOLOGICAL TISSUE ON ITS OUTER SURFACE. UPON FURTHER EXAMINATION, A HOLE AND HEMOSTAT CLAMP MARKS WERE OBSERVED ON THE OUTER SURFACE OF THE GRAFT. IT SHOULD BE FURTHER NOTED THAT THE MONOFILAMENT BEADING AROUND THE HOLE AREA WAS FOUND SEVERED AND PEELED OFF. SEVERAL IMAGES WERE THEN TAKEN OF THE EXTERIOR SURFACE OF THE EXPLANTED GRAFT SAMPLE USING A DIGITAL CAMERA. THE EXPLANTED SAMPLE WAS THEN STORED IN A 20% BLEACH SOLUTION TO SANITIZE PRIOR TO HANDLING AND MEASURING THE WALL THICKNESS. A 3-4MM LONG SEGMENT OF THE EXPLANTED GRAFT WAS CUT TO EXAMINE THE WALL THICKNESS. THE CUT SEGMENT WAS TAKEN FROM THE TRANSITION AREA WHERE THE GRAFT STARTS TO TAPER FROM 06MM TO 08MM. THIS LOCATION WAS REQUESTED FOR EVALUATION BY THE PHYSICIAN. FOUR WALL THICKNESS MEASUREMENTS WERE TAKEN ON THE SAMPLE USING A KEYENCE HIGH POWER DIGITAL MICROSCOPE. THE FOUR WALL THICKNESS MEASUREMENTS WERE: 0.023", 0.023", 0.024", AND 0.024". SINCE THERE IS NO WALL THICKNESS SPECIFICATION FOR THE TRANSITION AREA OF ALL TAPERED GRAFTS, A GRAFT SAMPLE FROM A RECENT PRODUCTION LOT (LOT #AJ12701) WAS MEASURED AT THE SAME LOCATION. FIVE WALL THICKNESS MEASUREMENTS WERE TAKEN AND WERE 0.024", 0.023", 0.022", 0.021" AND 0.024". ALSO, THE WATER ENTRY PRESSURE (WEP) WAS PERFORMED ON GRAFT SAMPLES FROM A PRODUCT LOT (LOT # 10815910). THE WEP VALUES WERE 21MMHG AND 192MMHG. THE WEP VALUES WERE 201MMHG AND 192MMHG. THE WALL THICKNESS OF THE EXPLANTED GRAFT IN THE AREA REQUESTED TO BE ASSESSED AND WHERE THE SEROMA HAD FORMED WAS COMPARABLE TO THE WALL THICKNESS OF A CURRENT PRODUCTION LOT. THE REVIEW OF THE LOT HISTORY RECORD TO INCLUDE WALL THICKNESS MEASUREMENTS AND WEP DEMONSTRATES THAT THE GRAFT WALL OF THE ENTIRE LOT MEETS WALL THICKNESS SPECIFICATION AT THE SMALL END (6M END) AND THE LARGE END (8MM END) OF THE TAPERED GRAFT. IT ALSO DEMONSTRATES THAT THE WEP VALUES MEET SPECIFICATION. SEROMA FORMATION WAS NOT CAUSED BY OUT OF SPECIFICATION GRAFT. THE VISUAL ANALYSIS OF THE PROVIDED SAMPLE DOES NOT REVEAL ANY POTENTIAL CAUSE OF THE SEROMA.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: ON (B)(6) 2008, THE LEFT FEMORAL ARTERY F-P BYPASS DUE TO ARTERIOSCLEROSIS OBLITERANS (ASO) WAS PERFORMED. ON (B)(6) 2009, SEROMA DEVELOPED THROUGHOUT THE LENGTH OF THE GRAFT AND THE CENTRAL PART OF THE GRAFT BECAME TOROSE, WHICH FORMED UNDER THE SKIN. ON (B)(6) 2009, THE PT PRESENTED WITH RED FLARE (THE SITE IS UNK) AND FEVER. THE PHYSICIAN PUNCTURED BY THE SUSPICION OF INFECTION BUT FOUND NO INFECTION IN THE PLASMA COMPONENT. THE PT WAS ADMINISTERED ANTI-INFLAMMATORY MEDICATION OF DASEN. ON (B)(6) 2009, THE PT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNK DATE OF 2009, SEROMA WAS NOTED AGAIN. ON (B)(6) 2012, RE-DO F-P BYPASS WAS PERFORMED WITH THE GRAFT REPLACED WITH ADVANTA PTFE GRAFT VXT SLIDER GDS (CATALOG 22212 SN (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656 ADVANTA PTFE VS GRAFT DYF ATRIUM MEDICAL CORP. 21745 AH14302

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention