BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERGARD WOVEN HEMABRIDGE

    MDR report key: 10072904 · Received May 19, 2020

    Report

    Report Number
    2242352-2020-00432
    Event Type
    Injury
    Date Received
    May 19, 2020
    Date of Event
    April 22, 2020
    Report Date
    July 21, 2020
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401001386
    PMA / PMN Number
    K013651
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (4112/4210-213) THE CASE HAS BEEN REVIEWED BY OUR CORPORATE MEDICAL OFFICER. HIS ASSESSMENT IS AS FOLLOWS : "THE EVENT RECORDED DESCRIBES THE USE OF AN INTERGARD WOVEN HEMABRIDGE GRAFT. THE TYPE OF INTERVENTION AND THE PATIENT'S CONDITION WERE NOT COLLECTED. THE SURGEON COMPLAINTS OF A SIGNIFICANT BLEEDING FROM WHAT I ASSUME IS THE BRANCH GRAFT. HE DESCRIBES THE BLEEDING AS DIFFUSED. WITHOUT DETAILED INFORMATION, REGARDING THE PROCEDURE I CAN ONLY ASSUME THE BRANCH GRAFT WAS USED FOR ARTERIAL PERFUSION AND CONNECTED TO THE EXTRACORPOREAL CIRCULATION. IN THIS CONFIGURATION, A SIGNIFICANT BLOOD FLOW IS BYPASSED FROM THE HEART-LUNG MACHINE TO THE ASCENDING AORTA AS THE HEART IS STOPPED. THE MANIPULATION OF THE VASCULAR GRAFT AND THE HIGH SHEAR STRESS DUE TO THE FLOW COULD HAVE AN EFFECT ON THE COLLAGEN COATING POTENTIALLY ALLOWING THE KIND OF BLEEDING THAT HAS BEEN OBSERVED. THE ANTICOAGULATION REGIMEN PLAYS ALSO A MAJOR ROLE IN THIS KIND OF EVENTS. THE LACK OF DETAILED INFORMATION DOES NOT ALLOW TO MAKE ANY FURTHER COMMENT." (4315) NO FURTHER INVESTIGATION CAN BE PERFORMED SINCE THE PRODUCT REMAINED IMPLANTED AND DUE TO THE LACK OF DETAILED INFORMATION, NO CONCLUSION CAN BE DRAWN. THEREFORE, THE CAUSE OF THE EVENT REMAINS UNKNOWN. HOWEVER, THE CONDUCTED INVESTIGATION SUGGESTS THAT THE DEVICE WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING. (22) PLEASE NOTE THAT ACCORDING TO THE INSTRUCTIONS FOR USE, "CARE SHOULD BE TAKEN WHEN HANDLING THE GRAFT TO AVOID DAMAGING THE COLLAGEN COATING." IN ADDITION, BLOOD LEAKAGE IS MENTIONED AS AN ADVERSE EFFECT IN THE INSTRUCTIONS FOR USE: ¿RISKS ASSOCIATED WITH THE IMPLANTATION OF ALL SYNTHETIC VASCULAR GRAFTS INCLUDE THROMBOSIS/OCCLUSION, ANASTOMOTIC INTIMAL HYPERPLASIA, RECURRENT SYMPTOMS, INFECTION, SEROMA FORMATION, BLOOD LEAKAGE, PSEUDOANEURYSM AND DILATATION OF THE GRAFT.¿.

    Description of Event or Problem · 0

    SEE INITIAL MFR REPORT#(B)(4). COMPLAINT #(B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT ACCESSIBLE FOR TESTING AS IT REMAINED IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORDS REVIEW CONCLUDES THAT THERE IS NO NON-CONFORMANCE / PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. THE REVIEW OF POST-MARKETING HISTORICAL DATA INDICATES THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER. A RETENTION SAMPLE FROM SAME LOT AND COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE INVOLVED DEVICE WAS IDENTIFIED. THIS RETENTION SAMPLE UNDERWENT WATER PERMEABILITY TESTING. THE TEST RESULT INDICATES A VALUE WELL WITHIN PRODUCT SPECIFICATIONS (< 5 ML/CM²/MIN). THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ISOLATED DIFFUSE WEEPING/ BLEEDING FROM THE COMPLETE SMALL CONNECTION TUBE. THE PHYSICIAN CUT THE CONNECTION TUBE AS MUCH AS POSSIBLE AND COMPRESSED THE TUBE SOME TIME. THEN HE LEFT IT IN THE PATIENT AND NO NEW BLEEDING OCCURRED. THE PATIENT WAS TRANSFUSED DUE TO MASSIVE BLOOD LOSS. STATUS OF PATIENT IS STABLE AND VERY GOOD NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536407 INTERGARD WOVEN HEMABRIDGE PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY INTERVASCULAR SAS HEW3210BRIDGE 19A24 00384401001386

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention