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

Model Number PVS23

Device Problems Perivalvular Leak (1457); Activation Failure (3270)

Patient Problem Aortic Regurgitation (1716)

Event Date 10/05/2020

Event Type  Injury  

Event Description

A perceval m was implanted as part of an avr on (b)(6) 2020.Immediately after indwelling, there was a trace paravalvular leak on the rcc side, but later, it worsened to mild.The device was explanted on (b)(6) 2020.On the same day, the operation was completed by indwelling a perceval l instead.When the heart was opened and the condition was checked before explant, part of the perceval on the rcc side was not fully expanded and there was a gap between the perceval and the annulus.When the valve was checked after explant, the inflow ring on the rcc side appeared to have a flattened curve.

Manufacturer Narrative

Fields updated: b4, b5, g4, g7, h1, h2, h6.The device was returned to the manufacturer for investigation.The visual inspection, performed on the returned prosthesis valve, did not highlight pre-existing defects.The height of each leaflet has been verified and it resulted in conformity.A deformation, consistent with the description reported in the case history and documented by the pictures received from the field, has been observed and documented once the device was received.This deformation showed the tendency to reduce after some days.This is an evidence that the feature observed in the returned prosthesis (i.E.''flattened area'') was reasonably induced by the implant time (11 days) and that it was not present before the implant and then therefore not attributable to a manufacturing deficiency.During the valve deployment and ballooning phase in the silicon aortic root, no problems were encountered.The valve positioning and sealing at the annulus level were guaranteed.The valve has remained fixed inside the annulus without showing significant anomalies or the tendency to create a potential path for perivalvular leak.The static leak test confirmed that no paravalvular leaks were observed during the simulation and the water level remained stable under the leaflets free edge.Furthermore, the manufacturing and material records for the perceval heart valve, model #icv1209 , s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.Based on the investigation performed, the event cannot be explained by any factor intrinsic to the device in question.No manufacturing nor quality deficits were identified during the investigation conducted on the returned prosthesis.Based on this result and on previous experience, the ''flattening area'' can be associated to a deformation induced by the interaction with the patient anatomy.Such a deformation could be consistent with the reported perivalvular leak, even if it was not possible to fully appreciate the deformation nor the presence of perivalvular leak from the performed investigation.Considering that at the time of the re-intervention, a decision was made to replace the explanted size pvs23 with a larger size (i.E.Pvs25), and that no further issues occurred after this second implant, the root cause of the reported event can be reasonably traced to an initial undersizing of the device, which could explain the presence of the inflow deformation and resulting perivalvular leak (firstly detected at the end of the first surgery).

Event Description

A perceval m was implanted as part of an avr on (b)(6) 2020.Immediately after indwelling, there was a trace paravalvular leak on the rcc side, but later, it worsened to mild.The device was explanted on (b)(6) 2020.On the same day, the operation was completed by indwelling a perceval l instead.When the heart was opened and the condition was checked before explant, part of the perceval on the rcc side was not fully expanded and there was a gap between the perceval and the annulus.When the valve was checked after explant, the inflow ring on the rcc side appeared to have a flattened curve.The patient recovered well and the new implant had no issues.There was no further information reported on the change of size from the pvs23 to the pvs25, but no annular enlargement was reportedly performed.No patient's unique geometries were identified, and no concomitant procedures were performed.

• 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: 10787955
• MDR Text Key: 214652057
• Report Number: 3004478276-2020-00229
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)230403
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2023
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 67