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

Model Number HEWROOT0028

Device Problem Product Quality Problem (1506)

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

Event Date 09/20/2022

Event Type  Injury  

Event Description

It was reported to intervascular from the health facility that: "there was an incident during a bentall procedure: a cardioroot prosthesis was put in place.The proximal part of the tube where the coronaries are reimplanted was deemed to be too porous and fragile, which led to small tears in the wires.Hemostasis was very complicated at the end of the procedure with a refitting of the cec, re-clamping of the aorta and the multiple use of coagulation factors and bioglue in particular.On (b)(6) 2022, the institution indicated that the patient has been admitted to the intensive care unit.The device will not be available for expertise (it remained on the patient)." complaint #(b)(4).

Manufacturer Narrative

Device is not accessible for testing as it remained implanted in the patient.After discussion with the pharmacist and the surgeon, the company representative provided the following answers : pre-existing medical conditions and health status history: medical: progressive ascending aortic aneurysm.Cardiovascular risk factors: hypertension, dyslipidemia, smoking cessation in 2006, overweight.Morphotype: 174 cm, 86 kg (bmi 28 kg/m²).Regarding the procedure, a bentall procedure with bioprosthesis and wrapping of the ascending aorta was performed.The procedure was significantly prolonged due to the event by 135 min extracorporeal circulation and 50 min of aortic clamping.The size and type of suture used for the anastomosis of the aortic prosthesis was prolene 5/0.The coronary buttons was prolene 4/0.The fenestrations for the coronary arteries were made using a thermocutter.Regarding the observed bleeding, there was no bleeding from areas other than the anastomosis.There was bleeding from a coronary button and there was no bleeding at the aorta-prosthesis anastomosis.About the event and its management: the consequences for the patient were prolongation in the operating room, post op surgical follow-up in prolonged intensive care.The reported issue had an impact on the patient's outcome and length of treatment with difficult haemostasis despite blood products transfusion, decision was made to return to extracorporeal circulation.In the immediate postoperative period, state of major hypovolemic shock with progressively on the first night the need for doses of noradrenaline up to 10mg/h and dobutamine at 10¿g/kg/min relayed by adrenaline 1mg/h despite a initial filling of 2000 ml of crystalloids, 1000 ml of bicarbonate and 500 ml of colloids.The consequence of this shock being a circulatory failure with a maximum lactate at 11.2 mmol/l and an anuric kdigo iii renal failure from the outset.It was confirmed that the graft remained implanted.Anlysis by the medical affairs manager is pending.The review of historical data indicated that there is no similar complaint for the sterilization lot number.The device history records review concluded that there was no non-conformance or planned deviation in relation with the event reported.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.Device is not accessible for testing as it remained implanted in the patient.

Event Description

See mfg initial report #(b)(4) complaint (b)(4).

Manufacturer Narrative

(4111/213) the case has been reviewed by the medical affairs manager whose assessment is below: "the complaint recorded describes a 48-year-old obese male with hypertension, dyslipidemia and a smoking history who underwent an ascending aortic aneurysm repair by way of a bentall procedure utilizing a 28 mm cardioroot vascular graft.The complainant stated that ¿the proximal part of the tube where the coronaries are reimplanted was deemed to be too porous and fragile, which led to small tears in the wires.Hemostasis was very complicated at the end of the procedure with a refitting of the cec, re-clamping of the aorta and the multiple use of coagulation factors and bioglue in particular.¿ blood products were administered, extracorporeal circulation was re-initiated (135 min extracorporeal circulation with 50 min aortic clamping).It was stated by the surgeon that 5-0 and 4-0 prolene sutures were used to sew the anastomoses and coronary buttons where the bleeding was noted.The graft remained implanted.Immediately post-op, the patient experienced ¿major hypovolemic shock¿ with the need for pressors and fluids (volume).According to the complainant, ¿the consequence of this shock being a circulatory failure.And an anuric kdigo iii renal failure¿ resulting in prolonged intensive care.It would be important to understand what the patient¿s coagulation paraments were intraoperatively and postoperatively as well as what techniques (other than the use of bioglue) were used to achieve hemostasis intraoperatively.The device history records review was conducted and concluded that there was no non-conformance / planned deviation in relation with the event reported and the reported event is isolated to this particular (cardioroot) product only.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 (such as friable tissue, difficult anatomy.), it is difficult to ascertain the exact cause of the anastomotic bleeding during the use of the prosthesis.As the graft remained implanted, macroscopic and histological examination of the explanted graft was not possible, however review of the retention product revealed no non-conformance.With the information available, it is reasonable to conclude that the bleeding may be due to patient anatomy, surgeon inexperience with the graft, or other surgical or technical factors and not the prosthetic graft." (11/213) a retention sample from the same sterilization lot, coated on the same day and under the same conditions as the involved device was visually inspected by the qa supervisor.No anomaly was found.This retention sample also underwent water permeability testing.The test result is 0,25 ml/cm²/min which is within specification (< 5 ml/cm²/min).The retention product underwent water permeability testing.Therefore, we conclude that the reported event is isolated and is related to the incriminated product only.(67) no conclusion can be drawn since the product remained implanted.However, the conducted investigation suggests that the device was not defective at the time of manufacturing.(22) please note that bleeding is an undesirable side effect as indicated in the instructions for use.

• 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: 15596615
• MDR Text Key: 301660958
• Report Number: 2242352-2022-00861
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401013907
• UDI-Public: (01)00384401013907
• 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: Distributor
• Source Type: Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEWROOT0028
• Device Catalogue Number: HEWROOT0028
• Device Lot Number: 22C31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2022
• Distributor Facility Aware Date: 10/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2022
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 86 KG