MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM AORTIC ARCH 4B; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M00202175928P0
Medical Device Problem Codes	Nonstandard Device (1420); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intervascular that during the preparation for the surgery, a discoloration was found on a part of the product likely due to the melting of collagen.The surgery was completed with a hemashield 4-branch (ref.M00202175926p0, sn (b)(6) available at the hospital, and it had no effect on the patient's condition or the surgical procedure.The involved product is available for examination.
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 24l13.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Additional Manufacturer Narrative
Corrected data: on block h6, medical device ¿ problem code was updated from 1506 to 1420 in accordance with the visual inspection results of returned product as described below.Additional mfg narrative: (10/170) the involved device was inspected by the production line lead, production supervisor and quality assurance (qa) engineer.The observations are as follows: the discoloration reported by the customer is located on the body of the graft.It is caused by an excess of collagen, which upon oxidation, has taken on a yellowish tint.The device was found non-compliant due to the size of the collagen cluster exceeding the acceptance criteria during quality control inspection.(4110/213) the occurrence rate was calculated for the similar events reported (including this complaint) for grafts and patches on the same manufacturing line (hemashield) for 1-year period from 01-jul-24 to 30-jun-25.The occurrence rate is (b)(4), which is below the maximum anticipated occurrence rate of 0.01% in the product risk assessment.(25) based on the investigation findings it was concluded that the yellowish discoloration observed on the product is due to the presence of excess collagen which is non compliant due to its size in regard to the acceptance criteria during quality control inspection.It should be noted that the defect has been assessed as cosmetic with no impact on patient safety or product performance, in accordance with the product risk review.
Event or Problem Description
(b)(4).

• Brand Name: HEMASHIELD PLATINUM AORTIC ARCH 4B
• 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: 22140598
• Report Number: 1640201-2025-0000012
• Device Sequence Number: 20671600
• Product Code: MAL
• UDI-Device Identifier: 00384401018650
• UDI-Public: (01)00384401018650
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: M00202175928P0
• Device Catalogue Number: M00202175928P0
• Device Lot Number: 24L13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown