BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCOL BIOLOGIC VASCULAR GRAFT

    MDR report key: 9163916 · Received October 7, 2019

    Report

    Report Number
    1220948-2019-00137
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    September 9, 2019
    Report Date
    October 7, 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 · 1

    WE HAVE NOT RECEIVED THE GRAFT FOR EVALUATION SINCE THE GRAFT HAS BEEN IMPLANTED. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE CAUSE OF THE FAILURE. HOWEVER, WE WERE ABLE TO OBSERVE THE REPORTED INCIDENT BASED ON THE PICTURES OF THE GRAFT THAT WAS PROVIDED TO US. WE OBSERVED MULTIPLE KINKS IN THE GRAFT IN THOSE PICTURES. PROCOL VASCULAR 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 DEFECTS INCLUDING KINKS IN THE GRAFT. EACH GRAFT IS AGAIN INSPECTED BY THE QC TECHNICIAN FOR THESE ATTRIBUTES. SUCH DEFECT IN THE GRAFT IS LIKELY TO GET CAUGHT DURING OUR INSPECTION PROCESS AND THE GRAFT GETS DISCARDED. THIS IS THE ONLY COMPLAINT WE HAVE RECEIVED RELATED TO GRAFT KINKING DEFECT SINCE WE ACQUIRED THIS PRODUCT LINE IN 2016. HENCE, WE CONSIDER THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    SURGEON USED A PROCOL VASCULAR BIOPROSTHESIS FOR CREATING A BRIDGE GRAFT FOR VASCULAR ACCESS TO A DIALYSIS PATIENT. AFTER SURGEON COMPLETED THE ARTERIAL ANASTOMOSIS, UPON PRESSURIZING THE GRAFT, HE OBSERVED MULTIPLE KINKS ON THE GRAFT. HE STATED THAT THE SUTURES WERE TIED DOWN EXTREMELY TIGHT WHICH COULD HAVE CAUSED THE GRAFT TO KINK AT THESE SPOTS. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958733 PROCOL BIOLOGIC VASCULAR GRAFT VASCULAR GRAFT LXA LEMAITRE VASCULAR, INC. UNKNOWN 00840663108688

    Patients

    Seq Age Sex Outcome Treatment
    1