MAUDE Adverse Event Report: LIVANOVA CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS21

Device Problem Degraded (1153)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Event Description

The manufacturer was informed on this event though the publication "sutureless and transcatheter aortic valve replacement: when rivals become allies" by ellouze et al.In the paper, it is reported that sutureless aortic valve replacement (su-avr) and tavr have emerged as viable alternatives to standard surgical avr in higher risk patients.This case series demonstrates that valve-in-valve tavr is feasible in the setting of a degenerated perceval sutureless bioprosthesis, and that su-avr is a useful strategy in the setting of a failed tavr requiring urgent surgery.Case 2 is presented as follows: an (b)(6) year old woman was diagnosed with severe symptomatic aortic stenosis and underwent suavr with a small (21 mm) perceval sutureless prosthesis, as well as coronary bypass grafts to the left anterior descending and obtuse marginal arteries.Four years later, she presented with worsening dyspnea on exertion, and was diagnosed with severe intra-valvular aortic regurgitation and elevated trans-aortic gradients.Her medical history was significant for type 2 diabetes and hypercholesterolemia.Given the patient¿s age, and the presence of patent coronary bypass grafts, our heart team decided to proceed with tavr.The procedure was carried out under mild sedation and via a transfemoral approach.Using rapid pacing and tee guidance, a 23 mm sapien valve was successfully deployed with excellent results.The mean transaortic gradient decreased from 34 mmhg to 7 mmhg.A pre-discharge echocardiogram showed an ava of 1.9 cm2, with no residual regurgitation.The patient was asymptomatic at follow-up 6 months after tavr.

Manufacturer Narrative

Fields updated: b4, f6, f7, f10 (updated coding).The manufacturer attempted to retrieve additional information on this event and the device involved.However, no further information has been provided to date.Since the serial number of the device remains unknown, and the device remains implanted, no investigation is possible at this time.Based on the available information, it is not possible to establish a definitive root cause for the reported event.It is possible that the patient¿s clinical history and risk factors (i.E.Type 2 diabetes and hypercholesterolemia) may have contributed to the structural valve deterioration observed in this perceval s valve.It should be noted that structural valve deterioration is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.The manufacturer will take further investigative actions and provide an update to this reporting activity should further information be received in the future.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 11210762
• MDR Text Key: 230754424
• Report Number: 1718850-2021-01005
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 12/22/2020,03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2020
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR