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

Model Number PVS23

Device Problems Collapse (1099); Leak/Splash (1354); Off-Label Use (1494)

Patient Problem Aortic Insufficiency (1715)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer received the device on oct.10, 2019 and performed a gross investigation.The returned valve was received in the original plastic jar with no liquid inside.The pericardium was covered by blood so it remained wet.

Event Description

On (b)(6) 2019 a patient received a perceval pvs23 as part of an avr.The manufacturer was notified that the device was explanted intra-operatively and replaced with a second medium perceval valve.The reported information is as follows.A medium valve was collapsed.The physician noted one of the sinusoidal struts was sticking out a little bit.The site decided to deploy the valve it anyway.When it was deployed it was obvious it did not deploy all the way in the same area identified beforehand, so the site adjusted the valve and it popped into place.They closed the aorta and checked the valve under tee, no leak was identified and it was fine.Once the patient was taken off clamp there was a huge paravalvular leak and when the site opened the aorta they noted the valve had popped back in on itself.A different medium valve was opened and was able to deploy just fine, so it was not a sizing issue.

Manufacturer Narrative

The valve pvs 23/m sn (b)(6) was returned to livanova for evaluation and it was received on october 10, 2019.A gross investigation was performed on the returned valve.The returned valve was received in the original plastic jar with no liquid inside.The pericardium was covered by blood so it resulted still wet.The manufacturer performed a visual inspection, collapsing simulation, device history record review and a deployment simulation.A complete manufacturing and material records review for the 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.The visual inspection performed on the returned prosthesis valve did not highlight pre-existing defects.The collapsing simulation highlighted a non-correct configuration of the metallic elements (overlapping).It is not possible to determine if this feature was the one claimed in the case history or if it is related to the manipulation during the explanting procedure.Nevertheless, there is a specific warning in the pvs ifu1, current release (i.E.Ic0215001345 rev.J), to check the valve struts before the implant.The deployment simulation performed on the returned valve did not highlight anomalies and/or deformations at the annulus level.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic in the involved device.The accessories used by the field were not returned, so it is not possible to state their potential involvement.It is not possible to totally exclude a mishandling, which occurred during the collapsing procedure and which compromised the entire implant procedure.However, because the root cause cannot be verified the conclusion is deemed to be cause cannot be established at this time fields changed: b4, g4, g7, h2, h6.

• 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: 9236095
• MDR Text Key: 166756961
• Report Number: 3004478276-2019-00297
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)220418
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2022
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention