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

Model Number PVS21

Device Problem Leak/Splash (1354)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1208, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp, including a review of the steady flow test.The results confirmed that this valve satisfied all material, visual, and performance standards required for a model #icv1208 perceval heart valve at the time of manufacture and release.Since the device remains implanted, no further investigation is possible at this time.Based on the information reported, it is not possible to establish the root cause of the reported moderate central regurgitation reported.However, based on the document review performed, no manufacturing deficits were identified.The manufacturing is presently following up to retrieve additional information on the event.The manufacturer will update the reporting activity should further information be received.

Event Description

On (b)(6) 2021, a perceval valve model pvs21 was implanted.A concomitant left atrial appendage closure was also performed.After de-clamp, an intra-prosthetic regurgitation (trace) was confirmed, but the amount was small.Then, extracorporeal circulation was terminated.Only central regurgitation occurred, and no peri-valvular leak was observed.It has been confirmed that there was no problem in the position by visual check immediately after indwelling or tee performed after the declamping.No positional abnormality was observed in the long-axis image of tee as well.While adjusting the volume of the heart, the regurgitation changed from trace to mild, and at the time of weaning, it changed to mild to moderate.Eventually, the chest was closed as it was and it was decided to follow up for a while.

• 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 V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 11382682
• MDR Text Key: 243891487
• Report Number: 3004478276-2021-00128
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)230917
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 57