BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEALPTFE

    MDR report key: 1821706 · Received August 27, 2010

    Report

    Report Number
    9612515-2010-00002
    Event Type
    Other
    Date Received
    August 27, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 27, 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 - DEVICE TO BE RETURNED TO VASCUTEK FOR EVAL. RESULTS: REVIEW OF MFG & QC RECORDS. THE MFG 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 39 UNITS WHICH WERE DISPATCHED IN (B)(6) 2009. WE HAVE NOT RECEIVED ANY OTHER SIMILAR REPORTS FROM THIS BATCH. THE USAGE RATE OF THIS PARTICULAR MODEL IS SUCH THAT IT MAY BE ASSUMED THE MAJORITY HAVE NOW BEEN IMPLANTED. 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. BLUMENBERG REPORTS OF A SURVEY OF 279 CASES WHERE PEIRGRAFT 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 BLUMENBERGL. FOUR PERCENT OF THE SEOMAS HE DESCRIBED WERE WITH AXILLOAXILLARY GRAFTS WITH EPTFE GRAFTS, ULTRA-FILTRATION OF SERUM THROUGH THE GRAFT WALL SEEMS THE LIKELY CAUSE OF SEROMA. IT IS POSSIBLE THAT SOME FLUID COLLECTS AROUND MANY GRAFTS, BUT IS MORE APPARENT IN TUNNELED DEVICES THAN THOSE IN THE ABDOMEN. IT IS ALSO POSSIBLE THAT SOME ABNORMALITY IN THE HEALING PROCESS ALLOWS SERUM TO PERMEATE THROUGH THE GRAFT WALL. PRICOLO TO THE SECOND POWER FOUND THAT SEROMA FLUID INHIBITED FIBROLBLAST GROWTH. IN SOME CASES, SEROMA HAS ONLY RESOLVED WHEN THE GRAFT TYPE WAS CHANGED, I.E., EPTFE TO POLYESTER, OR VICE-VERSA, SUGGESTING AN ALLERGENIC MECHANISM. SYMPTOMS WENT AWAY WHEN GRAFT WAS EXPLANTED. VASCUTEK WILL WRITE TO THE DOCTOR CONCERNED PROVIDING THE INFO GIVEN IN THE REFERENCES AND RESULTS OF THE GRAFT INVESTIGATION. VASCUTEK WILL FOLLOW-UP WITH A FINAL REPORT. BLUMENBERG RM, GELFAND ML AND DALE WA. PERIGRAFT SEROMAS COMPLICATING ARTERIAL GRAFTS. SURGERY 1985;97(2):194-203. PRICOLO VE, POTENTI F, SODERBERG CH. EFFECT OF PERIGRAFT SEROMA FLUID ON FIBROBLAST PROLIFERATION IN VITRO. ANNALS OF VASCULAR SURGERY 1991;5(5):462-466. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE EVENT OCCURRED AT (B)(6) IN (B)(6) USA. THE PT HAS END STAGE RENAL DISEASE AND HAD PLACEMENT OF VASCUTEK SEALPTFE GELATIN SEALED VASCULAR GRAFT FOR HEMODIALYSIS. POSTOPERATIVELY THE PT EXPERIENCED UNUSUAL SWELLING OVER THE INCISION OVER THE ARTERIAL ANASTOMOSIS. THE CAUSE WAS A COLLECTION OF SERUM. THE WOUND WAS TREATED WITH REPEATED ASPIRATION BUT THE FLUID KEPT RE-ACCUMULATING. THEN WOUND WAS RE-EXPLORED AND HE WAS FOUND TO HAVE EXCESSIVE ULTRAFILTRATION (WEEPING) THROUGH THE GRAFT ADJACENT TO THE ARTERIAL ANASTOMOSIS AND A 50 ML COLLECTION OF SERUM. THE GRAFT WAS REMOVED. THE DOCTOR REPORTED THESE SYMPTOMS WENT AWAY WHEN THE GRAFT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEALPTFE VASCULAR PROSTHESIS DSY VASCUTEK LTD. UNK P1747 1454

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R