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

Model Number HEWROOT0032

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/23/2024

Event Type  Death  

Event Description

It was reported to intervascular that during an appointment between the getinge sales representative and the initial reporter, on (b)(6) 2024, that the involved prosthesis was not good because it had bled and the patient had died.It was indicated that there were poor initial conditions, and the surgeon, used to the competitor's product had to resort to using the cardioroot.There were intraoperative coagulation disorders that were difficult to control.It should be noted that the surgeon did not provide any precise and concrete statements.He pointed out that it could have been due to many other circumstances and ruled out pure prosthesis failure and did not want to open a complaint.Moreover, the surgeon was not at the operating table until the end and could not completely rule out surgical failure.

Manufacturer Narrative

(4117) from the initial information received, it is unknown whether the product is available for analysis.(4109/3233) the review of historical data indicated that no similar complaint was reported for the same sterilization lot number 24a04.(3331/3233) a review of the device history records is pending.(4111/3233) to be noted that at this stage of the investigation, the product identification provided is based on the historical sales date of initial reporter, who ordered only 1 cardioroot after (b)(6) 2022 and the involved product was ordered in (b)(6) 2024.Attempts will be made to establish contact with the surgeon in order to clarifying the incident and acquiring additional details regarding the surgical intervention and patient conditions.(4110/213) from the outset of the investigation and due to the limited information received on the event, the occurrence of the bleeding events discussed at the previous monthly quality meeting (march 2024) was reviewed.The occurrence rate of bleeding events on intergard/hemagard products was within the maximum anticipated by the product risk assessment.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Complaint #(b)(4).

Manufacturer Narrative

Corrected data: on block d4, the product lot and serial number identification, and on block h4, the date of manufacture of the implanted graft were updated in accordance with the revised information provided by the initial reporter.Correct product implanted from lot 22j01 and serial number (b)(6).Additional manufacturer narrative: (4117) initially, no information was provided regarding the product's availability for analysis.However, the graft remained implanted in the patient.(4109/213) the review of historical data indicated that no similar complaint was reported for the same sterilization lot number 22j01.(3331/213) the device history records review concluded that no deviation was identified in relation with the reported event.(4111/213) additional information was provided following meeting between the getinge sales representative and the surgeon.On april 18, 2024, intervascular was informed of the following surgeon¿s statement: "the surgeon stated clearly and impressively that the cardioroot vascular prosthesis was implanted correctly and also functioned correctly.He expressly confirmed that there was no connection between our implant/product and post operative complications." no additional information on the surgical procedure and patient¿s conditions was provided.(3331/213) a thorough manufacturing data analysis was performed considering the limited information provided by the initial reported and due to the nature of the incident.The investigation report concluded that based on the analysis of the investigation findings, there are no element that could question the quality of the product at the time of manufacturing.Moreover, the final statement of the surgeon indicated that the product was not the cause of the complication.Since the product remained implanted, no further investigation could be performed.(11) a follow-up report will be sent upon completion of the medical assessment.

Event Description

Complaint #(b)(4).

Manufacturer Narrative

Corrected data: on block b1 and b2 were corrected as the outcome is related to adverse event and not the device itself.On block h6, the medical device problem code "3190" was replaced by code"2993" following the investigation findings as described below.Additional mfg narrative: (4112/213) the case and its investigation have been reviewed by the medical affairs department whose assessment, concluded the following: "due to the lack of information provided about the patient¿s medical history, medications being taken, hemostatic state before the surgery, nor any insight to the surgeon¿s impression of what occurred during the surgery, the only information provided was that the patient suffered a coagulation disorder during the surgery; as well as the fact that the graft was not made available for analysis, a definitive conclusion cannot be reached as to the performance of the device." (4315) based on the analysis of the investigation findings and according to the surgeon's final statement the device was not the cause of the patient's complications and the death is non device related.No conclusion can be drawn on the exact origin of the adverse event due to the lack of information provided regarding the patient¿s medical history and the surgery performed.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.(22) to be noted that bleeding is an undesirable side-effect as indicated in the current instructions for use.

• Brand Name: CARDIOROOT WOVEN
• Type of Device: 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: 18986070
• MDR Text Key: 338699329
• Report Number: 1640201-2024-00003
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401013921
• UDI-Public: (01)00384401013921
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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
• Device Operator: Health Professional
• Device Model Number: HEWROOT0032
• Device Catalogue Number: HEWROOT0032
• Device Lot Number: 22J01
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other