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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Device is not accessible for testing as it remained implanted in the patient.No information on the product is available (serial number, model, batch number) therefore no investigation on the product can be performed.The case description has been reviewed by the corporate medical affairs manager whose assessment is below: "this event, (date unknown and) reported on (b)(6) 2022, is described as a cardioroot graft implantation for a bentall procedure, where the surgeon stated that hemostasis and coronary reimplantation was difficult.Per the reporter, the graft remained implanted, and the patient is doing well.No additional information is available, and we have been informed that no more details will be provided.There was no mention if there were any intraoperative challenges, such as a complicated procedure, friable tissue, or difficult anatomy which may have contributed to surgeon¿s difficulty.Also not provided by the complainant are the patient¿s coagulation parameters during the procedure.It would be important to know if it was additional sutures or the reversal of heparin which resolved the hemostasis issue, and if the reimplantation of the coronaries was due to a technically difficult case or some other factor.It would also be important to understand where the issue of hemostasis occurred ¿ if it was needle hole bleeding around the anastomosis or blushing throughout the graft.There is no mention of the quantity of blood loss or if any blood products were administered to the patient.Also pertinent to the case is if the patient had any pre-existing health issues which would contribute to the difficulty that the surgeon experienced.No information regarding the size of or lot number of the graft implanted, therefore no investigation can be conducted on retention product from the same lot.In conclusion, based on the limited information provided in this complaint record and without knowing the surgical details regarding the implantation of the cardioroot vascular graft, it is difficult to ascertain the exact cause of the surgeon¿s difficulty.However, when taking into consideration the lack of a prolonged procedure and the positive patient outcome, it is reasonable to conclude that the issue was due to the patient anatomy and/or surgeon¿s inexperience with the graft and not the prosthetic graft itself." no conclusion can be drawn since the product remained implanted.However, the medical assessment suggests that the issue was not due to the product itself.

Event Description

It was reported to intervascular from the health facility that: "the establishment reported to us on (b)(6) 2022 a previous event (date of the event not known and not available): incident on a cardioroot (bentall procedure) difficult hemostasis and reimplantation of a coronary.The prosthesis remained implanted in the patient.The patient is doing well.No information is available as this is an earlier event." moreover, we received the information that "a revision in the operating room was necessary for reimplantation of one of the coronaries".

• Brand Name: CARDIOROOT
• 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: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 15603129
• MDR Text Key: 301732440
• Report Number: 1640201-2022-00033
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization