BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCOL BIOLOGIC VASCULAR GRAFT

    MDR report key: 12321636 · Received August 13, 2021

    Report

    Report Number
    1220948-2021-00079
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    June 29, 2021
    Report Date
    August 13, 2021
    Manufacturer
    LEMAITRE VASCULAR, INC
    Product Code
    LXA
    PMA / PMN Number
    P020049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE SECTION OF THE GRAFT WITH THE DEFECT FOR INVESTIGATION SINCE THE SECTION WAS DISCARDED BY THE USER. HENCE, WE COULD NOT CONFIRM THE EXACT NATURE OF THE REPORTED MALFUNCTION. PROCOL VACULAR BIOPROSTHESIS IS DERIVED FROM A SINGLE LENGTH OF BOVINE MESENTERIC VEIN THAT IS CHEMICALLY CROSS-LINKED WITH GLUTARALDEHYDE. NATURAL VARIATIONS EVEN IN THE SAME GRAFT IS POSSIBLE. COLLATERAL BRANCHES ARE LIGATED WITH SURGICAL SUTURE AND THE GRAFT IS INSPECTED UNDER PULSATILE FLOW CONDITIONS AT SIMULATED PHYSIOLOGICAL INTERNAL GRAFT PRESSURE. 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 SWOLLEN 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. A BATCH RECORD REVIEW COULD NOT BE CONDUCTED AT THIS TIME SINCE THE LOT NUMBER OF THE AFFECTED GRAFT WAS NOT PROVIDED. WE HAVE ALSO REVIEWED OUR COMPLAINT HISTORY FOR LAST 3 YEARS. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE. HENCE, WE CONSIDER THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE PROCOL GRAFT TORE DURING PRE-USE CHECK. THIS SECTION WITH THE DEFECT WAS CUT OFF AND THE REST OF THE GRAFT WAS IMPLANTED. THERE WAS NO HARM TO THE PATIENT AS THE RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216324 PROCOL BIOLOGIC VASCULAR GRAFT VASCULAR GRAFT LXA LEMAITRE VASCULAR, INC HJL016-40-N UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1