BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERGARD KNITTED AXILLO RS

    MDR report key: 19610453 · Received June 25, 2024

    Report

    Report Number
    2242352-2024-00731
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 27, 2024
    Report Date
    August 30, 2024
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401000877
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (10/213) THE SELECTED RETENTION SAMPLE FROM THE SAME STERILIZATION LOT, WITH THE SAME TEXTILE AND COATING PARAMETERS WAS VISUALLY INSPECTED BY THE QUALITY CONTROL TECHNICIAN AND THE MANUFACTURING SUPERVISOR, WHICH CONCLUDED THAT THE PRODUCT IS IN COMPLIANCE WITH THE PRODUCT SPECIFICATIONS. THIS RETENTION SAMPLE ALSO UNDERWENT WATER PERMEABILITY TESTING. THE TEST RESULT INDICATED A VALUE OF 0,68 ML/CM²/MIN WHICH IS WITHIN PRODUCT SPECIFICATIONS (< 5 ML/CM²/MIN). (11) THE COMPLETION OF THE INVESTIGATION CONCLUSION IS STILL ONGOING. A FOLLOW UP REPORT WILL SUBSEQUENTLY BE SENT.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: - ON BLOCK H6, THE MEDICAL DEVICE CODE 2975 WAS UPDATED TO 1494. ADDITIONAL MANUFACTURER NARRATIVE: (4112/4248) THE CASE AND ITS INVESTIGATION HAVE BEEN REVIEWED BY THE MEDICAL AFFAIRS DEPARTMENT WHO CONCLUDED THAT: "USE OF INTERGARD/HEMAGARD KNITTED GRAFTS IN THE THORACIC AORTA IS CONTRAINDICATED IN THE PRODUCT INSTRUCTIONS FOR USE. THE DEVICE WAS NOT SEWN TO THE AORTA PER SE, BUT THE SAME HEMODYNAMIC PRINCIPAL AND ANATOMIC LOCATION APPLIES AS IT WAS USED TO ANASTOMOSE MAIN BRANCHES OFF THE AORTA. DUE TO THE LACK OF THE BLEEDING SEGMENT FOR LABORATORY ANALYSIS, AS WELL AS THE LACK OF ADDITIONAL INFORMATION REGARDING THE PATIENT, OR THE SURGICAL PROCEDURE, THE CAUSE OF BLEEDING CANNOT BE DETERMINED. USE OF THIS DEVICE FOR THE PURPOSE OF AORTIC DEBRANCHING IS CONTRAINDICATED." (4110/213) OCCURRENCE OF BLEEDING EVENTS AND OFF-LABEL USE (OLU) BLEEDING EVENTS ARE REVIEWED MONTHLY DURING QUALITY MEETING, AS PER INTERNAL PROCEDURE. DURING LAST MEETING ((B)(6) 2024), THE BLEEDING EVENTS AND OLU BLEEDING EVENTS RATES ON INTERGARD/HEMAGARD PRODUCTS WERE WITHIN THE MAXIMUM ANTICIPATED BY THE PRODUCT RISK ASSESSMENT. (24) THE INVESTIGATION CONCLUDED THAT IT WAS NOT POSSIBLE TO IDENTIFY THE EXACT ORIGIN OF THE ADVERSE EVENT. HOWEVER, THE CONDUCTED INVESTIGATION SUGGESTS THAT THE PRODUCT WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING. TO BE NOTED THAT AS PER THE PRODUCT INSTRUCTIONS FOR USE, INTERGARD/HEMAGARD KNITTED VASCULAR GRAFTS ARE NOT INTENDED FOR USE IN THORACIC AORTA, AS A CORONARY ARTERY REPLACEMENT OR AS ARTERIOVENOUS SHUNT FOR VASCULAR ACCESS.

    Additional Manufacturer Narrative · 0

    (4114) BASED ON THE INITIAL INFORMATION RECEIVED, THE MAJORITY OF THE GRAFT REMAINED IMPLANTED IN THE PATIENT. THE CUT OFF FRAGMENT WILL NOT BE RETURNED FOR TESTING DESPITE REQUEST. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT THERE IS ANOTHER SIMILAR COMPLAINT REPORTED FOR THE SAME STERILIZATION LOT NUMBER 23C30 (COMPLAINT #(B)(4), MFR REPORT #1640201-2023-00020). THE CONDUCTED INVESTIGATION AND TESTING PERFORMED SUGGESTED THAT THE PRODUCT WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING. (3331/213) THE DEVICE HISTORY RECORDS ANALYSIS CONCLUDED THAT THERE WAS NO NON-CONFORMANCE IN RELATION WITH THE EVENT REPORTED. (11/3233) ONE SIMILAR RETENTION SAMPLE FROM SAME STERILIZATION LOT NUMBER WAS SELECTED BASED ON THE SAME COATING PARAMETERS, SAME PRODUCT MODEL AND SAME TEXTILE PARAMETERS AS THE INVOLVED DEVICE. ANALYSIS IN ONGOING. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. H3 OTHER TEXT : 4114 - BASED ON THE INITIAL INFORMATION RECEIVED, THE MAJORITY OF THE GRAFT REMAINED IMPLANTED IN THE PATIENT. THE CUT OFF FRAGMENT WILL NOT BE RETURNED FOR TESTING DESPITE REQUEST.

    Description of Event or Problem · 0

    COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CASE OF DEBRANCH TEVER (RIGHT SUBCLAVIAN ARTERY LEFT COMMON CAROTID ARTERY LEFT SUBCLAVIAN ARTERY BYPASS), AN INTERGARD KNITTED AXILOBIFEMORAL GRAFT WAS USED. DURING THE SURGERY, BLEEDING OCCURRED WHEN THE DISTAL SIDE OF THE GRAFT WAS EXTENDED TO ADJUST THE LENGTH OF THE GRAFT. THE BLEEDING WAS DIFFUSED AND LOCALIZED AT THE NON RADIALLY SUPPORTED PART OF THE GRAFT. BLEEDING WAS STOPPED BY CUTTING OFF THE LEAKING PART.. THE CUT SECTION WAS THEN ANASTOMOSED TO THE PATIENT'S BLOOD VESSEL. THE NON RADIALLY SUPPORTED WAS DESCRIBED BY THE DOCTOR AS LEAKING BLOOD LIKE AN UNCOATED ARTIFICIAL BLOOD VESSEL. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT, SUCH AS AN EXTENSION OF THE SURGERY TIME. COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697434 INTERGARD KNITTED AXILLO RS PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY INTERVASCULAR SAS IGKAX0808RS45/30 23C30 00384401000877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention