MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN AORTIC ARCH 1B; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M00202175826P0
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(10/3233) ithe involved device was returned to intervascular for examination.The investigation is ongoing.(4109/213) the review of historical data indicated that no other complaint was reported for the same sterilization lot number: 24d17.(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 surgery for aortic dissection, collagen dissolution was observed on the graft.The procedure was successfully completed using a stocked 1-branch 30 graft as a replacement, ensuring no adverse impact on the patient¿s condition.Complaint#: (b)(4).
Additional Manufacturer Narrative
(10/213) the involved device was returned to intervascular.A visual inspection was performed by the quality assurance engineer.The inspection results are the following: the visual inspection of the returned product did not confirm the "collagen dissolution" reported by the customer.However it identified the presence of yellow stains on the graft surface due to a localized collagen excess.This excess collagen results in a more yellowish appearance that is localized and more pronounced than on the rest of the prosthesis.Such spots are a known occurrence, and it can be confirmed that they are caused by collagen.But this is a known phenomenon that doesn't affect the product's performance or safety if no additional thickness is visible on the product, which is the case for the product in this complaint.The product therefore complies with the specifications.(67) the conducted investigation concludes that the returned product is conform to the product specifications.
Event or Problem Description
Complaint#(b)(4).

• Brand Name: HEMASHIELD PLATINUM WOVEN AORTIC ARCH 1B
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• 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: 24982471
• Report Number: 1640201-2026-0000023
• Device Sequence Number: 13384824
• Product Code: MAL
• UDI-Device Identifier: 00384401018568
• UDI-Public: (01)00384401018568
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00202175826P0
• Device Catalogue Number: M00202175826P0
• Device Lot Number: 24D17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male