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

Model Number PVF-L

Device Problem Difficult to Open or Close (2921)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/22/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval plus size l was implanted as part of an aortic valve replacement procedure.It was reported that, after implantation, one of the leaflets did not open properly and the valve had a severe central leak.The valve was consequently explanted and a biological sutured valve (avalus, exact size unknown) was ultimately implanted.The manufacturer was informed that, after the explant of the perceval valve, one leaflet appeared shorter than the others and, as reported, it was the same leaflet that appeared not properly opening after the implant.No other factor was identified potentially contributing to the central leak.The patient remained stable during the procedure and had no complications after the second valve was implanted.

Manufacturer Narrative

The manufacturing and material records for the perceval plus heart valve, model #pvf-l , s/n # (b)(6) , including a review of the steady flow test, as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #pvf-l) perceval plus heart valve at the time of manufacture and release.No anomalies are observed during the open/close cycle, with an acceptable open/close leaflet performance at the time of manufacture and release.The device involved in the reported event was returned to the manufacturer for investigation.After decontamination with formalin treatment, the valve was visually inspected without highlighting elements of non-conformity, resulting in compliance with the specifications required at the time of manufacture ad release.The height of each leaflet has been verified and it resulted in conformity.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 testing showed no anomalies during the open/close cycle in normotensive conditions.In hypotensive conditions, it seemed that the valve had some difficulty to reach the full open configuration, particularly on leaflet 2.However, it is important to highlight that the iso standard references are based on the normotensive conditions of test and, under this set-up, the valve resulted in compliance.Furthermore, comparing the test results obtained in hypotensive conditions with the original records (steady flow test performed at the time of manufacture and release), this behavior was not present.Since no leaflet anomaly was detected at the time of valve release, it is possible that the difficulty to reach a full opening by the leaflet 2 detected on the returned prosthesis may be a result of a not perfect storage conditions that could have caused an alteration of the pericardium properties in terms of elasticity / stiffening.Ultimately, analyzing the test results (at least limited, in conservative way, to the hypotensive conditions) in relationship to the description received from the field (i.E.Severe central leak), there is only a partial congruence.In fact, although a difficulty to reach full opening by the leaflet 2 has actually been observed, even if with the remarks discussed above, this behavior cannot in any way be considered as the cause of an incomplete closure / severe central leak.As also demonstrated by the results of the hydro test performed, good coaptation of the leaflets and no regurgitation was observed in both tests conditions.Based on the analysis performed, and the comparison with the original records, the reported event of severe central leak cannot be explained by any intrinsic factor in the device because no regurgitation was observed during the functional test under hydrodynamic testing conditions (both normotensive and hypotensive).Furthermore, no anomaly was detected in the leaflet's height of the returned device.Conversely, the not full opening by leaflet 2, although replicated in laboratory tests (in hypotensive conditions and only minimally in normotensive conditions) is not reflected in the original record, therefore it is not possible to exclude that what was observed in the laboratory was the consequence of suboptimal storage conditions.Considering the information reported regarding the device ultimately implanted (reportedly a smaller size than the perceval valve implanted), the most reasonable root cause based on the available information and investigations performed can be traced to a device mis-sizing.

Event Description

On (b)(6) 2021, a perceval plus size l was implanted as part of an aortic valve replacement procedure.It was reported that, after implantation, one of the leaflets did not open properly and the valve had a severe central leak.The valve was consequently explanted and the patient received a biological sutured valve (avalus, exact size unknown but reportedly smaller size than the perceval valve implanted).The manufacturer was informed that, after the explant of the perceval valve, one leaflet appeared shorter than the others and, as reported, it was the same leaflet that appeared not properly opening after the implant.No other factor was identified potentially contributing to the central leak.The patient remained stable during the procedure and had no complications after the second valve was implanted.

• Brand Name: PERCEVAL PLUS 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: 11572885
• MDR Text Key: 244849003
• Report Number: 1718850-2021-01042
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVF-L(17)220320
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 02/24/2021,04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2022
• Device Model Number: PVF-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/30/2021
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2021
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention