BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCOL BIOLOGIC VASCULAR GRAFT

    MDR report key: 9729589 · Received February 19, 2020

    Report

    Report Number
    1220948-2020-00021
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 20, 2020
    Report Date
    February 19, 2020
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    LXA
    UDI-DI
    00840663108688
    PMA / PMN Number
    P020049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE EXPLANTED GRAFT FOR EVALUATION. HOWEVER, WE WERE UNABLE TO INVESTIGATE THE RETURNED GRAFT. THE GRAFT HAS ALREADY DECAYED BY THE TIME OF OUR DEVICE EVALUATION SINCE IT WAS RETURNED TO US WITHOUT BEING SUBMERGERD IN STERILE SOLUTION. WE HAVE ALSO RECEIVED A PICTURE OF THE REPORTED DEFECT FROM THE SURGEON. IN THE PROVIDED PICTURE, WE OBSERVED THE PROXIMAL END OF THE GRAFT HAD DILATED TWICE THE DIAMETER OF ITS DISTAL SECTION. THE PROCOL GRAFT IS A NATURAL VEIN WITH COMPETENT VALVES. AS STATED IN THE IFU, THE BEVELED CUT END IS THE INFLOW END OF THE VESSEL. THE GRAFT SHOULD NOT BE IMPLANTED OR FLUSHED IN THE OPPOSITE DIRECTION OF FLOW AS COMPETENT VALVES MAY CAUSE EXCESSIVE PRESSURE AND DAMAGE THE INTEGRITY OF THE VESSEL. OUR INQUIRY WITH THE IMPLANTING PHYSICIAN REVEALED THAT HE BELIEVED THAT HE HAD IMPLANTED THE DEVICE IN THE CORRECT ORIENTATION. BUT THE PICTURE PROVIDED CONFLICTED WITH THAT DESCRIPTION. THEREFORE, WE ARE NOT CONCLUSIVE ON THE EXACT ROOT CAUSE OF THIS FAILURE. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS LOT DID NOT FIND ANY DISCREPANCIES EITHER IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS INCIDENT. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT. HENCE, WE CONSIDER THIS TO BE AN ISOLATED INCIDENT. PLEASE NOTE THAT EACH GRAFT IS PRESSURIZED BETWEEN 2.7-4.0 PSI ( 139 - 206 MMHG) DURING THE INSPECTION PROCESS. IF PRESSURE EXCEEDS 4 PSI, THE VESSEL IS REJECTED FOR 'OVERPRESSURIZED' AND DISCARDED. UNDER A PRESSURIZED CONDITION, EACH GRAFT IS INSPECTED BY THE MANUFACTURING OPERATORS FOR ANY PRESENCE OF HOLE, TEAR OR SWELLING. AN OD GAGE IS PASSED OVER THE ENTIRE LENGTH OF THE VESSEL. IF ANY SECTION OF THE GRAFT APPEARED TO BE DILATED OR DID NOT PASS THROUGH THE GAGE SMOOTHLY, THEN THAT SECTION OF THE GRAFT IS REJECTED BY THE TECHNICIAN. EACH GRAFT IS AGAIN INSPECTED BY THE QC TECHNICIAN FOR THESE ATTRIBUTES. PHYSICIAN IMPLANTED ANOTHER PROCOL VASCULAR GRAFT WITHOUT ANY ISSUE.

    Description of Event or Problem · 1

    SURGEON USED A PROCOL VASCULAR BIOPROSTHESIS FOR CREATING A BRIDGE GRAFT FOR VASCULAR ACCESS IN A DIALYSIS PATIENT. AFTER COMPLETION OF ARTERIAL ANASTOMOSIS, WHEN SURGEON REMOVED THE CLAMP AND THE GRAFT WAS UNDER ARTERIAL PRESSURE, HE OBSERVED THE PROXIMAL END OF THE GRAFT HAD DILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194373 PROCOL BIOLOGIC VASCULAR GRAFT VASCULAR GRAFT, LXA LEMAITRE VASCULAR, INC. HJL016-40-N PVB1044 00840663108688

    Patients

    Seq Age Sex Outcome Treatment
    1