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

Model Number PVS23

Device Problem Leak/Splash (1354)

Patient Problem Aortic Insufficiency (1715)

Event Date 02/27/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, a perceval implant attempt occurred.The mitral annular curtain, aorta and intra-annular portion are reportedly heavily calcified.The aortic annulus was sized and a perceval medium - pvs23 was selected.The valve collapsing, implant and ballooning were performed uneventfully.Post-implant, the coaptation of leaflets was good, no pinwheeling observed.The visual inspection implied that the pvs23 was correctly deployed and juxtaposed to anatomical structures.After weaning from bypass, the echo showed moderate to high central leak.Consequently, the patient was put back on bypass and the pvs23 was explanted.A decision was made to implant a sutured valve for this patient, who ultimately received an edwards magna ease size 21.It is reported that after the perceval explant, before the sutured valve implant, there was some calcium that was previously unseen that was debrided.The patient remained stable throughout the procedure, with a good outcome after surgery.

Manufacturer Narrative

After decontamination, the valve was visually inspected without highlighting elements of non-conformity, according to the specifications.A slight fold was noted on the third leaflet that could be likely related to manipulation during the explanting procedure.In order to allow an exhaustive evaluation of the functional behavior, the returned valve underwent hydrodynamic testing in simulated physiological conditions.The results of the hydrodynamic tests confirmed that no regurgitation was detected during the testing and that the pvs23 (sn (b)(6)) meets the iso 5840 minimum requirements.No anomalies were observed during the open/close cycle in normotensive conditions while, in hypotensive conditions, the third leaflet shows an anomalous behavior (not complete expansion during the open phase), possibly related to the slight fold observed and documented.However, it does not alter the coaptation in the closing phase.Ultimately, the claimed issue (i.E.Central leak/insufficiency) was not reproduced during the investigation carried out.The manufacturing and material records for the perceval valve model # pvs23 sn# (b)(6), as they pertain to the reported event, were retrieved and reviewed, including the review of the steady flow test images, by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a model # pvs23 perceval heart valve at the time of manufacture and release.Based on the analysis performed on the returned device, the reported event cannot be explained by any factor intrinsic in the involved device.No pre-existing defects were detected and the claimed issues (i.E.Central leak) were not reproduced during the investigation carried out.Furthermore, based on the document review performed, including the steady flow test review, it was confirmed that the slight fold noted on the third leaflet of the returned prosthesis was not present at the time of manufacture and release of the device and, therefore, can be reasonably related to manipulation occurred during the explanting procedure.Ultimately, the device complaint could not be confirmed based on the results of the investigation performed.

Manufacturer Narrative

The device was returned to the manufacturer and it was received on 14 apr 2020.Further investigation is ongoing and a follow-up report will be submitted once the device investigations are completed.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9886230
• MDR Text Key: 191197015
• Report Number: 1718850-2020-01048
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)221004
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020,06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2022
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2020
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2020
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 90