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

Model Number	HEWROOT0030
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not accessible for testing as it remained implanted in the patient.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 20m17.The device history records review concluded that there is no non-conformance / planned deviation in relation with the event reported.One retention sample from same sterilization lot number and coated on the same day and under similar conditions as the involved device, but with a different fabric type, was identified.A visual inspection by the qa department will be performed.One retention sample from another sterilization lot number (20m10), with the same fabric type as the involved device and coated 9 days before the involved device, was identified.A visual inspection by the qa department will be performed.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Surgical technique: re-operation with abscess in the specified area / aortic root replacement with edwards magna ease aortic valve and cardioroot.The valve was sewn into the cardioroot prosthesis and then placed and sewn in the aortic root area.The prosthesis was rinsed minimally with sterile nacl 0.9% solution before it was sewn.After sewing in, small detached particles were found on the inside.The surgeon suspected that the collagen coating was rubbing off or peeling off.After the clamps were released, the prosthesis was primarily tight and the prosthesis did not result in increased blood loss.The operation went without complications and the patient is doing very well.According to the doctor, the small detached particles were removed.We learned also that the surgeon was a new user of the cardioroot, this was the first time that the surgeon used the cardioroot.It was also mentioned that the surgeon did not have any difficulty for placing the valve.
Event or Problem Description
See initial mfg report number : # 1640201-2021-00018.Complaint #(b)(4).
Additional Manufacturer Narrative
(b)(4) one retention sample from same sterilization lot number and coated on the same day and under similar conditions as the involved device, but with a different fabric type, was identified.A visual inspection by the qa supervisor has been performed.No apparent defect was found on the product both internally and externally.(b)(4) one retention sample from another sterilization lot number (20m10), with the same fabric type as the involved device and coated 9 days before the involved device, was identified.A visual inspection by the qa supervisor has been performed.No apparent defect was found on the product both internally and externally.In addition, the complaint case has been reviewed by our medical corporate.His assessment is as follows : "the event describes the use of a cardioroot vascular prosthesis in a re-operation due to an abscess formation at the surgical site.According to the surgeon the graft was "minimally rinsed" using sterile saline solution but the temperature of the media was not mentioned.Small particles were detected in the inner surface of the graft.The surgeon suspected that the particles were collagen detaching from the graft but it wasn't confirmed.The material was removed and the graft was implanted successfully without any adverse event for the patient.The post-operative period was uneventful and the patient recovered as expected.It is improbable that the particles observed were made of collagen as this has not been observed before and the retention samples have shown no abnormalities.However it cannot be completely excluded.It is possible that the media used to rinse the graft contained small parts of surgical gauzes or other material that then was transferred in the graft lumen.The inability to analyze the particles makes this assessment not conclusive and only speculative.(4315) the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.No further investigation could be made without the defective product or detached particles sample.In accordance with our complaint procedures, we will continue to investigate such complaints and to monitor trends to detect any future alarming signal.

• Brand Name: CARDIOROOT
• 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
• MDR Report Key: 11950701
• Report Number: 2242352-2021-00456
• Device Sequence Number: 16432526
• Product Code: DSY
• UDI-Device Identifier: 00384401013914
• UDI-Public: (01)00384401013914
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Importer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021
• Report Date (Section F): 07/23/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: HEWROOT0030
• Device Catalogue Number: HEWROOT0030
• Device Lot Number: 20M17
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 07/23/2021