BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESPAN EPTFE VASCULAR GRAFT (REGULAR WALL)

    MDR report key: 2917892 · Received December 20, 2012

    Report

    Report Number
    1220948-2012-00024
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 30, 2012
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    DSY
    PMA / PMN Number
    K933590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR THE EVALUATION AND, WE WERE ABLE TO CONFIRM THE FAILURE. WE TEST THE RETURN PORTION OF THE GRAFT AND IT FAILED THE WATER ENTRY PRESSURE TEST. A LOT HISTORY INVESTIGATION WAS PERFORMED. THE DEVICE HISTORY RECORDS REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING EITHER THE MANUFACTURING OR THE PACKAGING PROCESSES AND THERE WERE NO UNRESOLVED ISSUES RELATED TO THE COMPLAINT EVENT. THIS LOT PASSED THE WATER ENTRY PRESSURE WHEN IT WAS RELEASED FROM THE PRODUCTION. THEREFORE, THE ROOT CAUSE OF FAILURE REMAINS INCONCLUSIVE. USUALLY, SUCH TYPE OF FAILURE HAPPENED WHEN THE GRAFT PRECLOT OR IMMERSE IN ANY SOLUTION (I.E ALCOHOL, OIL, OR AQUEOUS SOLUTIONS) PRIOR TO IMPLANTATION. WE BELIEVE IT WAS AN ISOLATED INCIDENT. ADDITIONALLY, THE COMPLAINT LOT WAS BUILT IN THE (B)(4) FACILITY WHICH WAS ACQUIRED BY (B)(4). FROM ANGIOTECH. LEMAITRE VASCULAR, INC. HAS CLOSED THE MANUFACTURING FACILITY IN (B)(4) AND TRANSFERRED THE RELATED PRODUCTION ACTIVITIES TO (B)(4). BY CENTRALIZING ALL OF OUR PRODUCTION ACTIVITIES INTO A SINGLE LOCATION, WE BELIEVE THAT WE WILL ENHANCE OUR QUALITY OF LIFESPAN PRODUCTS AND ALLEVIATE ISSUES YOU HAVE SEEN. PLEASE NOTE THAT NO PATIENT INJURY HAPPENED.

    Description of Event or Problem · 1

    PATIENT HAD END STAGE RENAL DISEASE AND UNDERGOING REVISION OF AN ARTERIOVENOUS GRAFT BY PLANNED CONSTRUCTION OF A POLYTETRAFLUOROETHYLENE JUMP GRAFT FROM THE RIGHT AXILLARY ARTERY TO AN EXISTING UPPER ARM PTFE RAFT. THE LIFESPAN 6 MM PTFE GRAFT WAS ANASTOMOSED FROM THE RIGHT AXILLARY ARTERY TO THE EXISTING PTFE GRAFT. AFTER REMOVAL OF THE VASCULAR CLAMPS THERE WAS HEAVY ULTRAFILTRATION (SWEATING) OF SERUM THROUGH THE GRAFT IN THE FIRST INCH OF THE GRAFT. THE GRAFT WAS EXCISED AND THE SEGMENT WITH EXCESSIVE ULTRAFILTRATION REPLACED WITH A 7 MM BOVINE GRAFT AND THERE WERE NO FURTHER PROBLEMS OBSERVED. PROLONGATION OF OPERATIVE PROCEDURE WAS ABOUT 45 MINUTES DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESPAN EPTFE VASCULAR GRAFT (REGULAR WALL) LIFESPAN EPTFE VASCULAR GRAFT 6X30 DSY LEMAITRE VASCULAR R06030 11011992

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R