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

Device Problems Gradient Increase (1270); Material Too Rigid or Stiff (1544)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 03/04/2019

Event Type  Injury  

Manufacturer Narrative

Device not explanted.

Event Description

A perceval valve was implanted on (b)(6) 2018 during a concomitant cabg procedure.The patient reportedly had a very small annulus, measuring 18 mm on toe intra-operatively.The sinotubular junction was reportedly tight, and the physician had difficulty reaching the annulus with the sizer.The anatomy was heavily calcified.The intra-operative gradient measurement was in the single digits, with no paravalvular leak.In (b)(6) 2019, follow-up toe showed a high gradient of 40 mmhg.The physician suspected hyper-attenuated leaflet thickening, and prescribed anticoagulation therapy.Follow-up was planned for 3-6 months from the initiation of anticoagulation.

Event Description

A perceval valve pvs21 was implanted on (b)(6) 2018 during a concomitant cabg procedure.The patient reportedly had a very small annulus, measuring 18 mm on toe intra-operatively.The sinotubular junction was reportedly tight, and the physician had difficulty reaching the annulus with the sizer.The anatomy was heavily calcified, but was debrided to the best of the surgeon's ability without stripping the annulus.The intra-operative gradient measurement was in the single digits, with no paravalvular leak.It was confirmed that no aortic root enlargement was performed prior to implant.In march 2019, follow-up toe showed a high gradient of 40 mmhg.The physician suspected hyper-attenuated leaflet thickening, and prescribed anticoagulation therapy.The patient was only on aspirin post-operatively, and was otherwise not on anticoagulation therapy.Follow-up was planned for 3-6 months from the time of therapy.It was considered that due to the poor visibility during sizing that mis-sizing may have been a contributing factor in the event.The implant procedure was reportedly a difficult case.

Manufacturer Narrative

The manufacturer received additional echo report data from the site on june 26, 2019.This information has been included in an updated event description in section b5.Hypoattenuated leaflet thickening (halt) is more common and may represent an early marker of leaflet thrombosis.Based on the information received the reported leaflet thickening and high gradient were resolved at the most recent fu as a result of anti-coagulation therapy.Because the gradient decreased with anti-coagulation there is no indication that the device performance or functionality was an attributing factor in the reported gradient increase or leaflet thickening.Because there are no longer any device related malfunctions or issues, no further investigations or actions will be taken by the manufacturer.The device history record could not be reviewed due to no follow-up information indicating the serial number received.At this time the root cause of the reported halt/thrombosis and consequent gradient increase is deemed to be related to the patients condition and is not related to the device performance or functionality.Fields changed: b4, b5, g4, g7, h2, h6.

Event Description

A perceval valve was implanted on (b)(6) 2018 during a concomitant cabg procedure.The patient reportedly had a very small annulus, measuring 18 mm on toe intra-operatively.The sinotubular junction was reportedly tight, and the physician had difficulty reaching the annulus with the sizer.The anatomy was heavily calcified.The intra-operative gradient measurement was in the single digits, with no paravalvular leak.In (b)(6) 2019, follow-up toe showed a high gradient of 40 mmhg.The physician suspected hyper-attenuated leaflet thickening, and prescribed anticoagulation therapy.Follow-up was planned for 3-6 months from the initiation of anticoagulation.Echo reports were received from the site on (b)(6) 2019.Echo imaging was performed on (b)(6) 2019 with the following results.The aortic valve bioprosthesis appeared seated well with no obvious paravalvular leak.Moderately elevated gradients (vmax 3.8m/s, mean pg 35mmhg, dpi 0.28 and avai 0.5cm/m^2 in the setting of normal svi 45ml/m^2, previously mean gradient = 14 mmhg and dpi 0.4 at svi 35ml/m^2 in (b)(6) 2018).Trivial aortic regurgitation.The mitral valve had mild mital annular calcification.Structurally and functionally normal mitral valve with no stenosis.Mild regurgitation.Other conclusions are as follows.Normal lv size and systolic function.Lvh.Mildly dilated left atrium.Echo imaging was performed again on (b)(6) 2019 with the following results.The aortic valve bioprosthesis opens well with trivial paravalvular leak.Normal gradient (lvot 1.7cm, vmax 2.3m/s, meanpg 11 mmhg, dpi 0.42 and avai 0.7cm/m^2).The mitral valve mild mitral has annular calcification with mildly thickened tips of mitral valve leaflets.No stenosis.Moderate regurgitation.Other conclusions are as follows.Normal lv size and systolic function.Lvh.Mildly dilated left atrium.Av bioprosthesis functions normally.Moderate/severe pulmonary hypertension.Moderate mitral regurgitation.

• 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: 8515401
• MDR Text Key: 142045129
• Report Number: 3004478276-2019-00148
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 06/17/2019; 06/26/2019
• Supplement Dates FDA Received: 06/17/2019; 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention