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

Model Number TBD

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

Patient Problems Aortic Insufficiency (1715); Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

Device not explanted.

Event Description

The manufacturer was notified of the following publication: innovations (phila).2019 sep 30:1556984519864938.Doi: 10.1177/1556984519864938.[epub ahead of print].Title: rescue balloon aortic valvuloplasty after sutureless aortic valve replacement for severe paravalvular leak.Authors: nagaoka e1, sato k2, hage a1, bagur r3, harle c2, asopa s1, kiaii b1.Author information/site: 1 division of cardiac surgery, department of surgery, western university, london health sciences centre, ontario, canada.2 department of anesthesia and perioperative medicine, western university, london health sciences centre, ontario, canada.3 division of cardiology, department of medicine, western university, london health sciences centre, ontario, canada.Abstract: sutureless aortic valve replacement (avr) is a wide-spreading new technology that provides short clamping time and excellent hemodynamic outcomes.However, among its possible complications is the risk of paravalvular leak.We present the case of a (b)(6) woman who underwent minimally invasive right mini-thoracotomy avr) with perceval s sutureless valve (livanova, london, uk).Intraoperative transesophageal echocardiography revealed severe paravalvular leak with stent distortion.Rescue balloon valvuloplasty was performed through the right femoral artery, and resulted in the resolution of the paravalvular leak.This case illustrates the utility and feasibility of balloon valvuloplasty in trouble-shooting sutureless aortic valve stent distortion, thus avoiding a repeat aortic cross-clamp and valve replacement.Keynote: the paper indicates: we elected to proceed with bav because we believed that the pvl was caused by stent distortion and we thought that it would be amenable to additional balloon valvuloplasty.This approach was found to be successful in our case, however, with the disadvantage of developing a third-degree av block due to the overexpansion of the aortic annulus.Summary: based on the information provided in the paper a patient received a perceval sutureless aortic heart valve implant (model, sn, size unknown) as part of an avr, via minimally invasive right mini-thoracotomy.Intraoperative transesophageal echocardiography revealed severe paravalvular leak with stent distortion.In order to treat the folding that had occurred the site chose to perform rescue balloon valvuloplasty through the right femoral artery.This resulted in the resolution of the paravalvular leak.Consequently the procedure resulted in the development of a third degree av block due to the overexpansion of the annulus and a permanent pacemaker implantation was required.The manufacturer is reporting the intra-operative difficulties resultant of a perceval folding occurrence after implantation.The pacemaker implantation as reported in the paper was a result of the procedural rescue balloon valvuloplasty which lead to overexpansion of the annulus and not a result of the perceval valve.

Manufacturer Narrative

Additional information received from dr.(b)(6) on january 16, 2019: no imaging is available.The sizing was performed with designated livanova perceval sizers like always.There was no doubt about the sizing.Not between two sizes.Patient had a bicuspid vale and hence had an ellipse shape annulus.The device serial number is presently not available.A follow-up was conducted and a tte was performed.The results looked completely fine.No evidence of paravalvular leak.There was no leak and the mean gradient was less than 12 mmhg.Because the device is not available for analysis and the serial number is unknown no further investigations can be performed.Based on the information reported in the paper it is clear that the bav procedure was the primary contributory factor leading to the pacemaker implantation.It is possible that the patients unique annulus geometry may have been a contributory factor leading the folding of the valve.However, follow-up identified that the prosthesis is functioning properly post-operatively after bav was performed.Based on the information available and the lack of possible investigations the root cause of the reported stent distortion and pvl is thus cannot be established.Please note that a field safety corrective action regarding stent folding of the perceval device was issued on june 22, 2018 (fsca (b)(4)).

Event Description

Additional information received from dr.(b)(6) on january 16, 2019: no imaging is available.The sizing was performed with designated livanova perceval sizers like always.There was no doubt about the sizing.Not between two sizes.Patient had a bicuspid vale and hence had an ellipse shape annulus.The device serial number is presently not available.A follow-up was conducted and a tte was performed.The results looked completely fine.No evidence of paravalvular leak.There was no leak and the mean gradient was less than 12 mmhg.

• 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: 9280974
• MDR Text Key: 165199312
• Report Number: 3004478276-2019-00303
• Device Sequence Number: 1
• Product Code: LWR
• 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,litera
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 63 YR