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

Model Number PVF-M

Device Problems Collapse (1099); Difficult to Fold, Unfold or Collapse (1254); Perivalvular Leak (1457); Material Deformation (2976)

Patient Problems Aortic Insufficiency (1715); No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval plus heart valve, model #pvf-m, s/n # (b)(4), 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 #pvf-m) perceval plus heart valve at the time of manufacture and release.The device was returned to the manufacturer and it was received on (b)(6) 2020.Further investigation is ongoing.

Event Description

On (b)(6) 2020, a perceval plus implant attempt occurred.It was reported that some difficulties were encountered mounting the valve.One leaflet looked poorly prepared within the collapsing device (leaflet appeared to be projecting outside of the frame).It was very difficult to then deploy the valve, as the mechanism appeared very stiff/stuck.After implanting the valve, a significant paravalvular leak was noted.When the prosthesis was removed, the corresponding area of prosthesis annulus was deformed with frame being bent inwards.A new pvf-m was ultimately collapsed, deployed and implanted with no issues.The patient remained stable throughout the procedure.

Manufacturer Narrative

The returned valve was received without storage liquid and the pericardium tissue appeared dehydrated.Due to the altered state of the returned prosthesis, as a result of incorrect storage conditions, no further testing nor judgment on the prosthesis was possible.The returned dual holder was freely moving in both closed and fully open positions even if once in full closed position, the posterior knob shown the tendency to remain in a stuck position.After the cleaning of the accessory, the replication of collapsing phases was performed using a demo pvf-m and the returned accessory.No problems were encountered with positioning the valve and no difficulty was observed during the collapsing phase.Both the outflow crown and the inflow skirt of the demo valve were collapsed and correctly captured by the returned holder.The simulation of deployment was completed without issue.Based on the analysis performed, the reported event cannot be explained by any intrinsic factor in the accessory involved because it was not possible to reproduce the reported collapse difficulties.No anomalies were observed during collapse and release replication, except for a slight tendency to a behavior reasonably similar to that one described in the event reported.Based on livanova experience of previous similar cases, it is not possible to exclude that the issue could be related to a not perceived exceeding rotation recovering the tip by means of the posterior knob.Ultimately, considering that no investigation on the returned prosthesis was possible given the altered status, a definitive root cause for the reported event cannot be established at this time.

• Brand Name: PERCEVAL PLUS SUTURELESS HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 10849101
• MDR Text Key: 218546729
• Report Number: 3004478276-2020-00232
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)220318
• Combination Product (y/n): N
• PMA/PMN Number: P150011S013
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2022
• Device Model Number: PVF-M
• Device Catalogue Number: PVF-M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention