MAUDE Adverse Event Report: INTERVASCULAR SAS HEMACAROTID KNITTED ULTRATHIN; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	HEK10/75CPUT (1)
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intervascular that when the product was opened prior to surgery, an oily stain on the internal tyvek lid was observed.The product was therefore not considered suitable for implantation.The user has been used intervascular¿s products for several years.Complaint #(b)(4).
Additional Manufacturer Narrative
(10/3233) it was reported that the involved device is available for testing, it should be returned to intervascular.(4121/213) the device history records review concluded that no deviation was identified in relation with the reported event.(4109/213) the review of historical data indicated that there is another similar complaint reported for the same sterilization lot number 24k03 (mfg report number: 1640201-2025-0000002 / complaint #(b)(4)).The complaints were originated from two different customers and were reported on nearby dates.The complaint investigation of the other reported case is still ongoing.A summary of the investigation will be provided once completed.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Additional Manufacturer Narrative
(4109/213) the investigation of the similar complaint reported on the same sterilization lot 24k03 concluded that the observed stains on the inner tyvek lid are glycerol stains caused by the product packaging design which can lead to a prolonged contact between the product and the inner tyvek lid during storage.Although this problem is well known, it has no impact on product quality or performance.(10/213) the involved device was returned to intervascular for analysis.The visual inspection was performed by the quality assurance supervisor, which concluded that the product is conform to the product specifications.The visual inspection of the product confirms the presence of a stain on the inner lid and no stains were found on the outer lid.The observed stain on the inner tyvek lid are glycerol stains.Indeed, the way the box is stored can lead to a prolonged contact between the product and the inner tyvek lid.Although this problem is well known, it has no impact on product quality or performance.It should be noted that the glycerol is used during the manufacture of the products.Its purpose is to maintain a sufficient level of moisture in the collagen layer of the prostheses and patches to keep them soft.(67) based on the investigation findings, in particular the visual inspection, it was determined that the product is conform to the product specifications.
Event or Problem Description
Complaint #(b)(4).

• Brand Name: HEMACAROTID KNITTED ULTRATHIN
• 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: 21652229
• Report Number: 1640201-2025-0000004
• Device Sequence Number: 7499244
• Product Code: DSY
• UDI-Device Identifier: 00384401001485
• UDI-Public: (01)00384401001485
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K983819
• Number of Events Summarized: 1
• Summary Report (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): 04/25/2025

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: HEK10/75CPUT (1)
• Device Catalogue Number: HEK10/75CPUT (1)
• Device Lot Number: 24K03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown