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

Model Number	M00202175828P0
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intervascular that during an ascending aorta replacement procedure, changes suggestive of collagen dissolution were noted on the graft surface during trimming.The graft was therefore replaced with a new one, and the procedure was completed without further issues.The affected graft is available for return upon request.
Additional Manufacturer Narrative
(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 25b05.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Complaint# (b)(4).
Additional Manufacturer Narrative
(3331/213) the device history records review concluded that there was no non-conformance in relation with the event reported.(10/213) the involved device was send to an external and independent laboratory for a macroscopic analysis.The macroscopic analysis of explant did not reveal any macroscopic defect in the textile structure.Little yellowish spots around the prosthesis and one larger spot inside one extremity were observed.The report was review by the quality assurance engineer, which concluded the following: the presence of yellowish stains from collagen is considered acceptable provided the stains remain within the height of the embossing crimps; and are attached to the graft (i.E, not free), which is the case for the involved product.The observed condition meets the defined acceptance criteria.Accordingly, the product complies with the product specifications.(67) based on the investigation findings, it was concluded that the involved product is conform to the product specifications.

• Brand Name: HEMASHIELD PLATINUM WOVEN AORTIC ARCH
• 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: 24017667
• Report Number: 1640201-2026-0000001
• Device Sequence Number: 13399418
• Product Code: MAL
• UDI-Device Identifier: 00384401018575
• UDI-Public: (01)00384401018575
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: M00202175828P0
• Device Catalogue Number: M00202175828P0
• Device Lot Number: 25B05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown