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

Model Number	HEWROOT0030
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
(4117) at the time of this report, it is unknown whether the product is available for analysis.(4118/3221) the serial number and sterilization lot number of the involved product are not available.The product identification and further information of the event are being sought to initiate the investigation.(11) the investigation is pending additional information.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported to intervascular that during a conversation between the sales representative and the hospital pharmacist on december 06, 2024, information about a patient's death was communicated, presumably following the implantation of a cardioroot prosthesis in (b)(6) 2023 (exact day not specified).At the time of this emdr, there is no further information on the case and an appointment between the sales representative and the surgeon is pending.It should be noted that the date of event in block b3 is set to may 1, 2023, as an approximation of the event date.The date will be updated later in a follow-up report as more information will become available.
Additional Manufacturer Narrative
Corrected data: in block d4, the suspected medical device information has been updated after a thorough product traceability review to identify the involved cardioroot, as detailed below.Additional manufacturer narrative: (4115) the involved device was explanted and discarded.(4112/213) the manufacturer conducted a thorough product traceability investigation to identify the involved cardioroot with model hewroot0028.The getinge sales operations manager (french subsidiary) confirmed that between jan 2022 and may 2023, only one cardioroot with model hewroot0030, serial number (b)(6) and lot number 21f10 was implanted at the involved hospital on (b)(6) 2022.Note that there was no cardioroot charged for this hospital in 2023; grafts are charged to hospitals once they are implanted.Therefore, it is not excluded that the initial information regarding cardioroot reference (hewroot0028) provided by the hospital regarding the complaint is not entirely accurate.(4121/213) the device history review (dhr) of the hypothetically involved cardioroot hewroot0030 (sn (b)(6) and lot# 21f10) was performed by the quality assurance supervisor in order to detect any relevant information that may have impacted the product and be related to the complaint.It was concluded that no deviation was identified in relation with the reported event.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21f10.(4110/213) the occurrence rate was calculated for the similar events reported (including this complaint) for grafts and patches on the same manufacturing line (intergard / hemagard) for 1-year period from 01-jan-24 to 31-jan-25.The occurrence rate is (b)(4), which is below the anticipated occurrence rate (maximum) of (b)(4) in the product risk assessment.(4112/4315) based on the limited provided information and the medical review, no conclusion can be drawn on the exact origin of the adverse event and the involvement of the device in the serious incident.As concluded in the medical review, due to the lack of any information regarding the patient, or the procedure, it is not possible to complete a medical assessment of the event.Moreover, the conducted investigation on the hypothetically involved cardioroot hewroot0030 suggests that the product was not defective at the time of manufacturing.
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: 21063480
• Report Number: 2242352-2025-00002
• Device Sequence Number: 3302271
• Product Code: DSY
• UDI-Device Identifier: 00384401013914
• UDI-Public: (01)00384401013914
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025
• Report Date (Section F): 02/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: HEWROOT0030
• Device Catalogue Number: HEWROOT0030
• Device Lot Number: 21F10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/11/2025
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/21/2025