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

Model Number	HEWROOT0028
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(4117) the device is not accessible for testing as it remained implanted in the patient.(4109/213) the review of historical data indicated that no other complaint was reported for the same sterilization lot number: 25c06.(4121/3233) a review of the device history records is ongoing, results are pending.(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 upon taken the graft out of the packaging without product handling prior use, it was noticed that part of the collar of the graft was frayed.The prosthesis was implanted and the operation went well.No injuries were reported on the patient.Complaint#: (b)(4).
Additional Manufacturer Narrative
Corrected data: on block h6, the method code "4121" was updated to "3331".Additional mfg narrative: (4109/213) the review of historical data indicated that no other complaint, with fraying without device manipulation, was reported for sterilization lots manufactured in 2025.(3331/213) the device history records review concluded that there was no non-conformance in relation with the event reported.In addition, an investigation was performed by the quality assurance supervisor who concluded that woven products naturally present a risk of fraying.During manufacturing, quality control technicians ensure the absence of fraying during product calibration followed by inspection.It appears very unlikely that fraying was present without the prosthesis being manipulated by the client.Indeed, as indicated in the the intergard woven instructions for use, the use of a thermocautery is recommended when cutting woven products to minimize fraying.Additionally, based on historical data analysis, no other product reporting fraying without prior handling has been reported in 2025.Based on the investigation findings, it is not possible to determine the exact cause of the defect observed by the client.However, the investigation findings suggest that the device was not defective at the time of its manufacture.(67) no conclusion can be drawn since the involved device remained implanted and no picture has been provided showing the observed fraying.It should be noted that it is very unlikely that fraying was present without the prosthesis being manipulated by the customer.Indeed, as per the intergard woven grafts instructions for use for, due to their intrinsic weaving pattern, woven grafts are more prone to fraying.The warning section states that woven grafts should not cut with scissors or scalpels to limit the risk of graft fraying.
Event or Problem Description
Complaint #(b)(4).

• Brand Name: CARDIOROOT WOVEN
• 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: 22043701
• Report Number: 1640201-2025-0000011
• Device Sequence Number: 12957143
• Product Code: DSY
• UDI-Device Identifier: 00384401013907
• UDI-Public: (01)00384401013907
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/23/2025

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: HEWROOT0028
• Device Catalogue Number: HEWROOT0028
• Device Lot Number: 25C06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown