BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERGARD KNITTED

    MDR report key: 8304062 · Received February 5, 2019

    Report

    Report Number
    1640201-2019-00006
    Event Type
    Injury
    Date Received
    February 5, 2019
    Date of Event
    December 30, 2018
    Report Date
    June 26, 2019
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401000471
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED GRAFT WAS ANALYZED BY AN EXTERNAL AND INDEPENDENT LABORATORY. THE MACROSCOPIC ANALYSIS SHOWED NO TEXTILE ABNORMALITY SUCH AS TEARS, LOSS OF TEXTILE COHESION, HOLES OR SIGNS OF CUT. SPECIFICALLY, NO SIGNIFICANT TEXTILE CHANGES WAS EVIDENCED AT THE BIFURCATION AREA. AT THE BASIS OF SUTURE LINE, ACCUMULATION OF BLOOD MATERIAL COULD BE DETECTED. THE SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF TWO SELECTED SEGMENTS (ONE OF EACH LEG OF THE BIFURCATED GRAFT) SHOWED MASSIVE BLOOD MATERIAL INFILTRATION THAT HINDERED APPRAISAL OF THE COLLAGEN MATERIAL. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (4315) THE CASE HAS BEEN ENTIRELY REVIEWED BY OUR CORPORATE MEDICAL OFFICER, WHO STATES THAT, "CONSIDERING ALL THE INFORMATION [...], IT IS NOT POSSIBLE TO MAKE ANY FURTHER STATEMENT REGARDING THE CAUSE OF THE BLEEDING". THE CAUSE OF THE EVENT REMAINS UNKNOWN. HOWEVER, THE CONDUCTED INVESTIGATION SUGGESTS THAT THE DEVICE WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING.

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS SENT TO AN EXTERNAL AND INDEPENDENT LABORATORY FOR EXAMINATION. THE INVESTIGATION IS ONGOING. A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO ESTABLISHED PROCEDURES AND WAS THEREFORE RELEASED FOLLOWING ACCEPTABLE QUALITY INSPECTIONS AND TESTS. SPECIFICALLY, NO ANOMALY WAS EVIDENCED IN THE COLLAGEN COATING RECORDS. MOREOVER, THE REVIEW OF THE WATER PERMEABILITY TESTING RECORDS OF PRODUCTS COATED ON THE SAME PERIOD/DAY AS THE COMPLAINT DEVICE INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS (< 5 ML/CM²/MIN). ONE RETENTION SAMPLE COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE INVOLVED DEVICE UNDERWENT WATER PERMEABILITY TESTING. THE TEST RESULT INDICATED A VALUE WELL WITHIN PRODUCT SPECIFICATIONS (< 5 ML/CM²/MIN). THE REVIEW OF POST-MARKETING HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT NUMBER. A VIDEO OF THE SURGERY WAS PROVIDED BY THE USER, SHOWING EVIDENCE OF THE BLOOD LEAKAGE. THE CORPORATE MEDICAL OFFICER CAREFULLY OBSERVED THIS VIDEO AND COMMENTED THAT "BECAUSE OF THE TWO BRANCHES ARE CLAMPED TOGETHER AND AT 90 DEGREES ANGLE FROM THE PROXIMAL ANASTOMOSIS, IT IS DIFFICULT TO ACCURATELY DISCRIMINATE WHERE THE BLEEDING IS COMING FROM. IT DOES APPEAR THAT IT IS COMING MOSTLY FROM AN AREA AT THE GRAFT BIFURCATION AND TO BE A CONTINUOUS STREAM WITH PULSATILE FLOW CHARACTERISTICS (NOT DIFFUSED)." THE COMMENTS FROM R&D ARE THE FOLLOWING: "AT A FIRST GLANCE, IT LOOKS LIKE THE BLEEDING WAS MOSTLY ORIGINATING FROM THE CROTCH, HOWEVER, LOOKING AT A LOWER SPEED, IT SEEMS THAT BLEEDING FIRST OCCURRED ON THE LEGS BEFORE AFFECTING THE CROTCH ." THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AFTER THE BIFURCATED GRAFT WAS PLACED IN THE PATIENT, BLOOD OOZED FROM ALL OVER THE GRAFT. THE AMOUNT OF BLOOD LEAKAGE IS UNKNOWN. THE SURGEON REPLACED IT WITH ANOTHER GRAFT WITH REFERENCE IGK1608 (I.E. ONE WITH A LARGER DIAMETER) AND NO BLOOD LEAKAGE OCCURRED WITH THIS SECOND GRAFT. THE SURGERY WAS PROLONGED FOR 15-20 MINUTES. THE GRAFT IS AVAILABLE FOR INVESTIGATION. A VIDEO OF THE BLEEDING IS AVAILABLE FOR INVESTIGATION. THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97927 INTERGARD KNITTED VASCULAR POLYESTER GRAFT DSY INTERVASCULAR SAS IGK1407 17C02 00384401000471

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention