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

Model Number PVS23

Device Problems Perivalvular Leak (1457); Off-Label Use (1494)

Patient Problem Aortic Insufficiency (1715)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned to the manufacturer and it was received on 27 sep 2019.The returned valve was received slightly blood stained but still in generally good conditions.The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova (b)(6) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.

Event Description

On (b)(6) 2019, a perceval implant attempt occurred.The patient presented with a stenotic, bicuspid aortic valve.Upon intraoperative inspection at the echo, it was determined that the annulus was circular and it was decided to proceed with a perceval implant.The native valve was excised and the annulus was debrided, the annulus was sized and determined to be suitable for a pvs23 valve.After implanting the valve, upon weaning from cardiopulmonary bypass (cpb) it was identified by the echo that there was a significant paravalvular leak in the non-coronary region of the annulus along with a central leak.No stent folding was detected.The aortic cannula was noted to be somewhat malpositioned and was subsequently repositioned; it was felt that this may have augmented the central leak.The cpb was then reinitiated and the valve was removed, recollapsed and reimplanted, having re-confirmed that the medium size valve was indeed the correct size and that the annulus had indeed been adequately debrided.Upon weaning from cpb it was again determined by echo that there was still a significant paravalvular leak seen in the same non-coronary region of the annulus.Stent in-folding was also detected this time.Consequently, the cpb was reinitiated and the perceval valve was explanted.A perimount 23 was implanted.The patient remained stable throughout the procedure and no complications were reported.No apparent issue with the explanted pvs23 was reported.

Manufacturer Narrative

The visual inspection performed on the returned prosthesis confirmed the absence of pre-existing defects.The deployment simulations and the static leak tests, performed on the returned valve, did not highlight evidence of paravalvular leaks and / or particular deformations at the annulus level.Based on the performed analysis, the reported event is reasonably associable to the peculiar anatomy of the patient (i.E.Bicuspid valve).However, it is important to highlight that according to pvs ifu, the re-collapsing and the attempt of re-implantation is an out of label because the valve integrity is no longer ensured.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9168919
• MDR Text Key: 161811070
• Report Number: 1718850-2019-01102
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)220429
• 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: 09/12/2019,11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2022
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2019
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2019
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention