MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN AORTIC ARCH; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	HEWAA3010080810/1
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(4111/3233) attempts to obtain more information about the product and the adverse event are ongoing.(10/3233) based on initial information received, the involved product is available for testing.The product should be returned to an external and independent laboratory for examination.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 24m05.(4121/213) the device history records review concluded that there was no non-conformance in relation with the reported event.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported to intervascular that during aortic arch surgery, excessive blood loss occurred along the entire branch connecting to the cardiopulmonary bypass (cpb).Complaint #(b)(4).
Event or Problem Description
Complaint #(b)(4).
Additional Manufacturer Narrative
Corr.Data: on block b1, the type of report "adverse event" plus "product problem" was corrected to only "adverse event".Addtl mfg narrative: (4111/3221) attempts to obtain more information about the product and the adverse event were performed.At the end of the investigation, no further information was provided by the surgeon.(10/213) the involved device was returned to an external and independent laboratory for examination.The macroscopic analysis of explant did not reveal any macroscopic defects in the textile structure.(4112/213) the case and its investigation have been reviewed by the medical affairs department who concluded that due to the lack of information provided regarding the patient, specifically the coagulation profile, the length and level of complexity of the procedure, or the handling of the graft prior to its use, a conclusion of the cause of the reported bleeding cannot be determined.Prolonged clotting time, abnormal platelet count, deficiency of clotting factors can increase the likelihood of bleeding.The mishandling of the graft as described in the ifu: ¿care should be taken when handling the graft to avoid damaging the collagen coating.Avoid clamping the graft.If surgical technique requires cross-clamping of the graft, use atraumatic clamps.¿ prolonged surgical procedures may increase the likelihood of bleeding due to hemodilution, platelet disfunction, and the potential activation of coagulation and fibrinolysis.(4315/22) no conclusion can be drawn on the exact origin of the event due to the lack of information provided regarding the patient, the procedure, or the handling of the graft prior to its use.Nevertheless, the investigation findings suggests that the device was not defective at the time of manufacturing.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.

• Brand Name: INTERGARD WOVEN AORTIC ARCH
• 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 ; 442084646
• MDR Report Key: 22009788
• Report Number: 1640201-2025-0000010
• Device Sequence Number: 7893746
• Product Code: DSY
• UDI-Device Identifier: 00384401010760
• UDI-Public: (01)00384401010760
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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 Model Number: HEWAA3010080810/1
• Device Catalogue Number: HEWAA3010080810/1
• Device Lot Number: 24M05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown