BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELSOFT AX-BIFEM EQUI-ERS REINFORCEMENT

    MDR report key: 1880582 · Received October 20, 2010

    Report

    Report Number
    9612515-2010-00009
    Event Type
    Other
    Date Received
    October 20, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 20, 2010
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VASCUTEK WILL CARRY OUT AN INVESTIGATION ON THE GRAFT WHEN IT IS RETURNED. RESULTS: 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 6 UNITS WHICH WERE DISPATCHED (B)(6) 2009. THE CT IMAGES AT (B)(6) 2010 SHOW THAT THERE WERE NO ISSUES WITH THE GRAFT. THE CT IMAGE AT (B)(6) 2010 SHOW THAT ALMOST CIRCULAR LOOP HAS FORMED. VASCUTEK WILL CARRY OUT ANALYSIS OF THE GRAFT ON ITS RETURN. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE EVENT OCCURRED AT (B)(6) HOSPITAL IN (B)(6). THE EVENT IS BEING REPORTED DUE TO INTERVENTION REQUIRED FOR GRAFT REPLACEMENT 9 MONTHS AFTER IMPLANT. IN (B)(6) 2009, THE PATIENT WAS IMPLANTED WITH AN AXILO-BIFEMORAL BYPASS. IN (B)(6) 2010, THE DOCTOR DID NOT FIND ANY ABNORMALITY USING CT. IN (B)(6) 2010, THE DOCTOR FOUND SWELLING ON SIDE OF THE BODY, BUT THE PATIENT DID NOT FEEL ANY ABNORMALITY SUCH AS PAIN. THE DOCTOR DID NOT BELIEVE IT WAS A SEROMA AND FOUND A SECTION OF THE HAD MOVED TO FOR A CIRCULAR SHAPE BY CT. THE DOCTOR PERFORMED GRAFT REPLACEMENT USING ANOTHER GRAFT. HE DID NOT FIND ANY INFECTION SYMPTOMS NEAR THE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELSOFT AX-BIFEM EQUI-ERS REINFORCEMENT VASCULAR PROSTHESIS DSY VASCUTEK LTD. UNK 97868/1 1461

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R