BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCOL BIOLOGIC VASCULAR GRAFT

    MDR report key: 8445484 · Received March 22, 2019

    Report

    Report Number
    1220948-2019-00028
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    February 21, 2019
    Report Date
    April 23, 2019
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    LXA
    UDI-DI
    00840663108688
    PMA / PMN Number
    P020049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION AND WE HAVE CONFIRMED THE REPORTED INCIDENT. UPON PRESSURIZING THE GRAFT, A SECTION OF THE GRAFT ( ~ 1 INCH) TOWARDS THE OUTFLOW END WAS OBSERVED TO HAVE DILATED. THE DILATATION WAS OBSERVED TO BE LIMITED TO ONLY ONE SIDE IN THIS SECTION OF THE GRAFT RATHER THAN ITS ENTIRE CIRCUMFERENCE. THERE WAS NO LEAKAGE OBSERVED IN THE GRAFT DURING GRAFT PRESSURIZATION. THE GRAFT WAS THEN DISSECTED. WE DID NOT OBSERVE ANY COMPETENT VALVES IN THE GRAFT. THE SECTION THAT WAS OBSERVED TO HAVE DILATED WAS ALSO FOUND TO BE THINNER AND APPEARED TO HAVE OVER-PRESSURIZATION DAMAGE. THE INTIMA OF THIS SECTION WAS DAMAGED AND WAS PULLED APART. A STITCHING OF THE SIDE BRANCH WAS OBSERVED NEAR TO THIS THINNER SECTION OF THE GRAFT. HOWEVER, IT DID NOT APPEAR THE THINNESS/DAMAGE TO THE GRAFT WAS CAUSED DUE TO PULLING OF THE GRAFT MATERIAL DURING SUTURING AS A SECTION OF THE GRAFT IN BETWEEN THEM WERE OBSERVED TO BE NORMAL. PROCOL VACULAR BIOPROSTHESIS IS DERIVED FROM A SINGLE LENGTH OF BOVINE MESENTERIC VEIN THAT IS CHEMICALLY CROSS-LINKED WITH GLUTARALDEHYDE. COLLATERAL BRANCHES ARE LIGATED WITH SURGICAL SUTURE AND THE DEVICE IS INSPECTED UNDER PULSATILE FLOW CONDITIONS AT SIMULATED PHYSIOLOGICAL INTERNAL GRAFT PRESSURE. NATURAL VARIATION EVEN IN THE SAME GRAFT IS POSSIBLE. EACH GRAFT IS PRESSURIZED BETWEEN 2.7-4.0 PSI ( 139 - 206 MMHG) DURING INSPECTION PROCESS. IF PRESSURE EXCEEDS 4 PSI, THE VESSEL IS REJECTED FOR 'OVERPRESSURIZED' AND DISCARDED. UNDER 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. WE HAVE CONDUCTED A LOT HISTORY REVIEW AND DID NOT FIND ANY ISSUES NOTED IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS ISSUE. ALL QC TESTS PASSED THEIR REQUIREMENTS. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE RELATED TO OTHER GRAFTS THAT WERE MANUFACTURED IN THIS BATCH. WE THEREFORE BELIEVE THIS IS AN ISOLATED INCIDENT. AT THIS TIME, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS FAILURE. OUR IFU PROPERLY INSTRUCTS USERS TO USE LIGHT PRESSURE WHEN IRRIGATING THE GRAFT AND NOT FLUSH IT IN THE OPPOSITE DIRECTION OF THE VALVES, WHICH MAY COMPROMISE THE INTEGRITY OF THE VESSEL. THE IFU ALSO INFORMS USERS NOT TO USE FORCEPS TO GRIP THE GRAFT AS IT MAY DAMAGE THE GRAFT.

    Description of Event or Problem · 0

    DURING PRE-USE CHECK, SURGEON OBSERVED THE DISTAL SECTION OF THE GRAFT TO HAVE DILATED.

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE GRAFT FOR EVALUATION. THE DEVICE IS CURRENTLY ON TRANSIT AND IS EXPECTED TO ARRIVE AT THE MANUFACTURING SITE ON THE WEEK OF 03/25/2019. AT THIS TIME, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT. 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. THEREFORE, WE BELIEVE THAT IT WAS AN ISOLATED INCIDENT. SURGEON OBSERVED THE ATTRIBUTE ON THE GRAFT THROUGH ITS GLASS PACKAGE AND THE GRAFT WAS NOT REMOVED FROM ITS PACKAGING.

    Description of Event or Problem · 1

    SURGEON OBSERVED AN ANEURYSM ON THE DISTAL SECTION OF THE GRAFT. THE ATTRIBUTE WAS VISIBLE THROUGH ITS GLASS PACKAGE AND THE GRAFT WAS NOT REMOVED FROM ITS PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235659 PROCOL BIOLOGIC VASCULAR GRAFT VASCULAR GRAFT LXA LEMAITRE VASCULAR, INC. 016-T2925-03 00840663108688

    Patients

    Seq Age Sex Outcome Treatment
    1