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

Model Number PVS21

Device Problems Collapse (1099); Leak/Splash (1354)

Patient Problems Aortic Insufficiency (1715); Death (1802)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned to the manufacturer on oct.3 2019 and a gross investigation was performed.The device was returned in general good conditions.

Event Description

On tuesday (b)(6) a perceval pvs21 sutureless aortic heart valve was implanted in a combined procedure avr-cabg in a (b)(6)-yr old female patient with a high risk score due to several comorbidities.The annulus was measured at 2,37 cm.Per-op the valve was examined and no abnormalities were observed.The site performed one balloon inflation after placing the valve and poured warm saline over it according to the ifu.One venous graft was placed concomitantly.The site performed distal anastomosis before the valve implantation, the proximal after closing the aortotomy.Regarded as a normal implantation sequence.Patient went off cardiopulmonary bypass and was brought to the icu.After a few hours the patient woke up and recovered in the icu.During the night (tuesday to wednesday) the clinical situation of the patient worsened.On the echo on wednesday morning a severe leakage of the (perceval) aortic valve was observed; not clear if it was valvular or paravalvular.Considering the condition of the patient it was decided to re operate the patient.The same surgeon opened the aorta and identified a folding of the perceval stent at the non-coronary cusp.The surgeon concluded this was the cause of the leakage and therefore explanted the perceval and replaced it with a trifecta size 19.During the re-operation the anesthetist had some problems in understanding/reading the bis monitor and when coming of bypass the patient had a low blood tension, however technically the procedure was completed successfully.The patient however did not wake up in the icu and when the mechanical support for the patient was stopped, the patient passed away (wednesday afternoon).

Manufacturer Narrative

The device was returned to the manufacturer and it was received on oct.03, 2019.A complete manufacturing and material records review for the stent component has been performed.The results confirmed that the component satisfied all material, visual and performance standards required at the time of manufacture and release.A preliminary visual inspection was performed in order to record the gross appearance of the returned valve in its as received conditions.Photographs of the device were taken during this step.The dimensional verification confirmed that the returned pvs 21/s valve meets the specifications.A simulation of collapsing, deployment and ballooning phases was performed in order to attempt to replicate the reported event.The deployment and ballooning phases were performed in a silicon aortic root, size 21, reinforced at the annulus level by means of an o-ring, in order to mimic the anatomical condition.The collapsing procedure was completed per procedure and no difficulties were observed.A minor overlapping phenomena was observed at post 1, however, this alteration can be reasonably associated with the manipulation of the valve during the explant.During the simulation of the valve deployment in silicon aortic root 21, no problems were encountered during the ballooning phase of the returned valve: the sealing at the annulus level is guaranteed and the valve remained fixed within the annulus.Based on the reported paravalvular leak a static leak test was performed on the deployed valve.The static leak test was performed by inserting some water in the aortic root from the outflow side.No paravalvular leaks were observed during the simulation and the water level remained stable under the leaflets free edge.An echocardiography review was performed by medstar core lab.Their interpretation summary is as follows.Moderate to severe ai which is mostly central.The leaflets seem to be intact, however there is one leaflet with restricted motion in the left/ non coronary position.Adjacent to this leaflet, there seems to be an incomplete stent expansion/ folding, likely to be responsible for uneven coaptation of the leaflets and resulting central ai.Based on the performed analysis, the reported event was not replicated, as no evidences of folding behavior nor specific features that might have induced it were observed during the investigation process.No manufacturing nor quality deficits were identified during the document review.Based on livanova's clinical research, device oversizing is the most probable root cause of events involving stent folding.However, based on the case history reported, this cannot be ultimately confirmed.Thus, the root cause for this event cannot be established at this time.

• 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: 9176999
• MDR Text Key: 161919780
• Report Number: 3005687633-2019-00230
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)211123
• 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: 11/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2021
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 11/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 74 YR