MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED AXILLO BIFEMORAL; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	HGKAX0808
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was submitted as part of the intervascular pmcf registry on april 4, 2017, the patient with aortic occlusive disease in the iliac region had 100 percent pre-procedure stenosis.An intergard standard axillo bifemoral graft was implanted, an iliac stent was also implanted.During this procedure suture hole bleeding occurred and a local hemostatic agent (type unknown) was used to arrest the bleeding.Technical success was achieved, and the patient was discharged on april 18, 2017 on may 28, 2017, 54 days after the initial implant, the patient experienced thrombosis of the crossed branch of the axillo-bifemoral bypass.The severity was noted as moderate and the investigator noted this was possibly related to the procedure and possibly related to the device.On february 4th, 2022, 4 years, 10 months after the initial implant procedure the patient experienced periprosthetic collection.Three separate complaints were created for these three events.Accordingly, three individual emdr submissions will be submitted for each event.This report is the third in a series of three reports submitted for this patient.
Additional Manufacturer Narrative
(4117) the device is not available for evaluation.Based on available information, the implanted graft remains in situ and was not explanted.Therefore, no physical device analysis can be performed.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 15m24.(3331/3233) the device history records review is ongoing.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
(b)(4).
Additional Manufacturer Narrative
(4110/213) occurrence rate of periprosthetic collection events was calculated at 0,0001%, which is below the defined limits for periprosthetic collection.(3331/3233) the device history records review concluded that no deviation was identified in relation with the event reported.(67) based on the investigation findings , no conclusion can be drawn on the exact origin of the adverse event.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.

• Brand Name: HEMAGARD KNITTED AXILLO BIFEMORAL
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; +033 442084646
• MDR Report Key: 24604559
• Report Number: 2242352-2026-00004
• Device Sequence Number: 10458578
• Product Code: DSY
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026
• Report Date (Section F): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: HGKAX0808
• Device Catalogue Number: HGKAX0808
• Device Lot Number: 15M24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/24/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 103 LB
• Date Report Sent to FDA: 05/22/2026