BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERGARD WOVEN AORTIC ARCH

    MDR report key: 23389911 · Received October 27, 2025

    Report

    Report Number
    2242352-2025-00911
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    September 2, 2025
    Report Date
    January 27, 2026
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401010753
    PMA / PMN Number
    K013651
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIVE DATA: ON BLOCK B1, THE ADVERSE EVENT/PRODUCT PROBLEM FIELD INITIALLY REPORTED WAS ¿PRODUCT PROBLEM¿. IN FOLLOW-UP REPORT 1, THIS IS UPDATED TO ¿ADVERSE EVENT / PRODUCT PROBLEM¿. ADDITIONAL MANUFACTURER NARRATIVE: (4117) THE DEVICE IS NOT ACCESSIBLE AS IT REMAINED IMPLANTED IN THE PATIENT, THEREFORE NO ANALYSIS COULD BE PERFORMED. (4111) THE FOLLOWING ADDITIONAL INFORMATION WERE RECEIVED FROM THE GETINGE SALES REPRESENTATIVE: PROCEDURAL INFORMATION: PROCEDURE PERFORMED: GRAFT REPLACEMENT. INDICATION FOR SURGERY: AORTIC ANEURYSM. IMPACT ON THE PROCEDURAL OUTCOME: NONE. CONSEQUENCE FOR THE PATIENT: NONE. DESCRIBE THE BLEEDING: LOCAL. PATIENT¿S MEDICATION: HYPOTENSIVE DRUGS. AMOUNT OF BLOOD LOSS: ABOUT 200CC. WHERE WAS THE BLEEDING NOTED: ALONG A SUTURE LINE/ANASTOMOSIS. WHAT ACTIONS WERE TAKEN TO STOP THE BLEEDING: ADDITIONAL SUTURES. THE EXTENSIVE BLEEDING MADE HEMOSTASIS DIFFICULT. POSTOPERATIVE DRAINAGE WAS EXTENSIVE. THE TUBE REMOVAL TIME WAS LONG. MEDICAL HISTORY: HYPERTENSION THE GRAFT WAS NOT EXPLANTED AND NOT AVAILABLE FOR INVESTIGATION. THEY ALSO INDICATED THAT THERE IS NO FURTHER INFORMATION FOR THIS COMPLAINT. (4112/213) THE CASE AND ITS INVESTIGATION HAVE BEEN REVIEWED BY THE MEDICAL AFFAIRS DEPARTMENT; HOWEVER, DESPITE REPEATED ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTING SURGEON, ONLY LIMITED INFORMATION WAS AVAILABLE, LEADING TO THE FOLLOWING CONCLUSION:: "THIS IS A COMPLAINT REGARDING AN INTERGARD WOVEN AORTIC ARCH IMPLANTED IN (B)(6) ON (B)(6) 2025. IT WAS REPORTED THAT A PATIENT BLED APPROXIMATELY 200 CC FROM ONE OF THE BRANCHES OF THE AORTIC ARCH DEVICE, ALONG THE SUTURE LINE. ADDITIONAL SUTURES WERE PLACED TO ACHIEVE HEMOSTASIS. REQUESTS FOR ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. CONSIDERING THE LIMITED AMOUNT OF INFORMATION PROVIDED IT IS DIFFICULT TO UNDERSTAND IF THERE WERE ISSUES WITH THE GRAFT, THE PROCEDURE OR THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN." (4110) OCCURRENCE OF BLEEDING EVENTS ARE REVIEWED MONTHLY DURING QUALITY MEETING. IN DEC 2025, THE BLEEDING EVENTS RATES ON INTERGARD STANDARD PRODUCTS WERE WITHIN THE MAXIMUM ANTICIPATED BY THE PRODUCT RISK ASSESSMENT. (4315) DUE TO THE LIMITED INFORMATION PROVIDED, NO CONCLUSION CAN BE DRAWN ON THE EXACT ORIGIN OF THE EVENT. NEVERTHELESS, THE INVESTIGATION FINDINGS SUGGEST THAT THE DEVICE WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING. (22) TO BE NOTED THAT BLEEDING IS AN UNDESIRABLE SIDE-EFFECT AS INDICATED IN THE CURRENT PRODUCT INSTRUCTIONS FOR USE, IN THE "UNDESIRABLE SIDE-EFFECTS" SECTION.

    Additional Manufacturer Narrative · 0

    (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 24G25. (4111/3233) ATTEMPTS TO CONTACT THE USER TO GET MORE INFORMATION OF THE REPORTED ADVERSE EVENT ARE BEING PERFORMED. AT THE DATE OF THIS REPORTING, THE FOLLOWING INFORMATION HAS BEEN RECEIVED: - THE PATIENT HAS AN HISTORY OF HYPERTENSION. - THE PROCEDURE PERFORMED WAS A GRAFT REPLACEMENT AND THE INDICATION FOR SURGERY IS AORTIC ANEURYSM. - THE BLEEDING IS DESCRIBED AS LOCAL AND ALONG A SUTURE LINE / ANASTOMOSIS. ADDITIONAL SUTURES WERE DONE TO STOP THE BLEEDING. - IT WAS REPORTED THAT THERE WERE NO IMPACT ON THE PROCEDURAL OUTCOME AND NO CONSEQUENCE FOR THE PATIENT. THE GRAFT REMAINED IMPLANTED AND WILL THEREFORE NOT BE AVAILABLE FOR EVALUATION. (3331/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON-CONFORMANCE IN RELATION WITH THE EVENT REPORTED. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    COMPLAINT # (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED TO INTERVASCULAR FROM THE HEALTH FACILITY THAT DURING A GRAFT REPLACEMENT SURGERY FOR AORTIC ANEURYSM, BLEEDING OCCURRED ON THE BRANCH OF THE GRAFT. THE BLEEDING WAS DESCRIBED AS LOCAL AND ALONG A SUTURE LINE / ANASTOMOSIS. ADDITIONAL SUTURES WERE DONE TO STOP THE BLEEDING. IT WAS REPORTED THAT THERE WERE NO IMPACT ON THE PROCEDURAL OUTCOME AND NO CONSEQUENCE FOR THE PATIENT. COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2797793 INTERGARD WOVEN AORTIC ARCH PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY INTERVASCULAR SAS HEWAA2810080810/1 24G25 00384401010753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown