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

Model Number PVS21

Device Problem Leak/Splash (1354)

Patient Problem Aortic Regurgitation (1716)

Event Date 03/06/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, aortic valve replacement was performed with mitral valve replacement and tricuspid annuloplasty.Sizing was carefully performed under proctor supervision so that the stent post of the mitral valve did not protrude into the lvot, then epic 25m was placed.The transparent side of the size s sizer passed through the annulus, and the white side of the size s sizer passed with some few resistance.The white side of the size m sizer did not pass through the annulus.Because the sizing was repeated several times and the results were the same, the size s was chosen.A perceval pvs21 size small was implanted.After visual confirmation of the placed position, there was wrinkle on the aortic wall where the aorta contacted the stent frame.Thus, the wrinkle was smoothed, and the placed position was confirmed again, then the aorta was closed.After de-clamping, it was confirmed that the placed position was proper by echo.Physio tricuspid 28mm was implanted.Perceval was placed higher than the annulus, it was confirmed that perceval moved up and down with the beat.Cross clamping was conducted again.Part of the annulus of perceval was squeezed, and the position was carefully confirmed, then incision site of the aorta was closed.After de-clamping, the site tried to confirm that the placed position was proper and there was no pvl.However, they were unable to visualize the right coronary cusp by the transesophageal echocardiography (tee).Then the heart lung machine was taken off.Tee before hooking the sternal wire also showed that there was no change of the placed position, the operation was completed.On (b)(6) 2020, pvl was confirmed by the transthoracic echocardiography (tte).Tee was performed to confirm the detail.Pvl was not observed in the initial view, but severe pve was observed after changed view.The leakage was observed at the right coronary cusp.There is a gap between the inflow-ring and annulus, and the leakage was occurred from the gap.Thus, valve in valve (tavi) was planned on the same day, however firstly the valvuloplasty by the balloon dilatation was tried to seal the gap.Perceval slipped to aorta side during dilatation of the balloon (22mm), because the position of the balloon was too deep.Perceval was pushed into the left ventricle side and fixed.After rapid pacing, perceval was completely dropped from the annulus position, the operation was changed to emergency thoracotomy with pcps.Perceval was explanted and inspiris 21mm was implanted.Cpb time was 117 minutes, x-clamp time was 76 minutes.The patient's condition was stable as of the afternoon of (b)(6) 2020.

Manufacturer Narrative

The manufacturer followed up for the return of the device and was notified the device is not available for return and analysis.In addition the site did not provide any information regarding their hypothesized root cause of the event.The manufacturing and material records for the perceval heart valve, model #icv1208 , s/n (b)(6) as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.Because the device was not returned no further analysis could be performed.The review of the device history record confirmed the device met all required standards at the time of manufacture and release.From the reported event information the event appears to be a result of a procedural malpositioning and patient factors.No anomalies were identified with the device stent and it was reported a wrinkle it the patients annulus was present and that the device was malpositioned in the annulus (placed high).The site reportedly attempted to correct this malpositioning but were unable to confirm proper positioning of the right coronary cusp via tee after declamping.The combination of these factors can reasonably be associated with the pvl which was identified due to an incomplete sealing between the device stent and the patients annulus.In addition it should be noted that the device ifu highlights the following: "warning: if during or after prosthesis release there is any sign of poor seating that could impair proper valve functioning, remove the prosthesis following instructions given under "prosthesis removal procedure".Because the device was not explanted and the site attempted to correct the malpositioning through manipulation of the annulus the event can be regarded as an off ifu action.The conclusion of this event investigation is thus deemed to be cause traced to user : failure to follow instructions.

• 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: 9927072
• MDR Text Key: 191197116
• Report Number: 1718850-2020-01061
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)230129
• 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: 03/06/2020,07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1209
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/06/2020
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2020
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention