BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMAGARD KNITTED

    MDR report key: 8509888 · Received April 12, 2019

    Report

    Report Number
    1640201-2019-00023
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    March 15, 2019
    Report Date
    June 12, 2019
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401015093
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (11/213) TWO RETENTION SAMPLES FROM SAME LOT AND COATED ON THE SAME PERIOD (ONE AND TWO DAYS LATER) AND UNDER THE SAME CONDITIONS AS THE INVOLVED DEVICE UNDERWENT WATER PERMEABILITY TESTING. THE TEST RESULTS INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS (< 5 ML/CM²/MIN). (67) NO CONCLUSION CAN BE DRAWN SINCE THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. HOWEVER, THE CONDUCTED INVESTIGATION AND TESTING PERFORMED SUGGEST THAT THE PRODUCT WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING. (24) PLEASE NOTE THAT, AS PER THE PRODUCT INSTRUCTIONS FOR USE, THE USE OF KNITTED VASCULAR GRAFTS AS A CONDUIT FOR CANNULATION IS NOT AN APPROVED INDICATION. INDEED, HEMAGARD KNITTED VASCULAR GRAFTS ARE INDICATED FOR SURGICAL REPAIR, BYPASS, OR REPLACEMENT OF ARTERIES IN THE TREATMENT OF ANEURYSMAL AND OCCLUSIVE DISEASE OF THE ABDOMINAL AORTA, VISCERAL ARTERIES, AND PERIPHERAL ARTERIES.

    Additional Manufacturer Narrative · 0

    INTERVASCULAR SAS (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF MAQUET CARDIOVASCULAR, LLC (IMPORTER), ACCORDING TO THE EXEMPTION E2017024. (4117) DEVICE IS NOT ACCESSIBLE FOR TESTING AS IT REMAINED IMPLANTED IN THE PATIENT. (3331/213) 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 DAY AS THE COMPLAINT DEVICE INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS (< 5 ML/CM²/MIN). (11/3233) A RETENTION SAMPLE FROM SAME LOT AND COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE INVOLVED DEVICE WAS IDENTIFIED AND WILL UNDERGO WATER PERMEABILITY TESTING. (4109/213) THE REVIEW OF POST-MARKETING HISTORICAL DATA INDICATED THAT ONLY ONE SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT NUMBER. THE CONDUCTED INVESTIGATION SUGGESTED THAT THE DEVICE WAS NOT DEFECTIVE. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CASE WAS A ZONE ZERO THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). THE GRAFT WAS USED TO ALLOW FOR AN AXILLARY BYPASS FOR ACCESS PURPOSES. PATIENT WAS HEPARINIZED FOR PROCEDURE. BLOOD WAS STREAMING FROM GRAFT LIKE A WATERFALL WITH SIGNIFICANT BLOOD LOSS. THE GRAFT WAS WRAPPED WITH THROMBOGENIC MATERIAL TO CONTROL THE BLEEDING. PATIENT WAS FINALLY STABILIZED AND IS RECOVERING IN HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301995 HEMAGARD KNITTED VASCULAR POLYESTER GRAFT DSY INTERVASCULAR SAS HGK0010-100 15G02 00384401015093

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention