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

Model Number PVS23

Device Problem Degraded (1153)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Type  Injury  

Manufacturer Narrative

Other text: valve-in-valve procedure, not explanted.

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 1 is presented as follows: a (b)(6) year-old woman presented with severe symptomatic aortic regurgitation and stenosis three years after implantation of a medium-sized (23 mm) perceval sutureless prosthesis.The patient was in new york heart association (nyha) functional class iii.Her medical history was significant for type 2 diabetes, obesity, hypothyroidism, hypercholesterolemia, and end-stage renal disease.A decision was made to proceed with tavr rather than reoperation.Given the patient¿s high surgical risk.The procedure was carried out under mild sedation and via a transfemoral approach.Using rapid pacing and transesophageal echocardiographic (tee) guidance, a 26 mm corevalve was successfully deployed inside the degenerated perceval prosthesis with excellent result, and an angioplasty of the left anterior descending artery was concomitantly performed.The mean transaortic gradient decreased from 40 mmhg to 9 mmhg.A pre-discharge echocardiogram showed an aortic valve area (ava) of 1.4 cm2, with trivial regurgitation.The patient was asymptomatic at follow-up 8 months after tavr.

Manufacturer Narrative

Fields updated: a3 (correction), b4, h1, h2 (additional information chosen as a placeholder, no additional information received), h6.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, obesity, hypothyroidism, hypercholesterolemia, and end-stage renal disease) 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: 11210561
• MDR Text Key: 230752914
• Report Number: 3004478276-2021-00115
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• 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: 79 YR