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

Model Number PVS25

Device Problems Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/11/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, a patient was intended to received a perceval valve as part of an aortic valve replacement.A perceval pvs25 (l size) was initially sized, the white end of sizer passed through the annulus with slight pressure.The xl sizer did not pass through the annulus.A pvs25 was therefore deployed.After the ballooning, the valve appeared well positioned, with the leaflets coapting at same height and the annulus not visible above or below the perceval annular level, thus pvs25 appeared well implanted.The aorta was closed and, after weaning from by-pass, the perfusionist was having trouble getting pressures up - pulmonic pressures and system pressures equalized.It was noticed that the valve had migrated.After having re-sized the annulus, the xl sizer passed through the annulus with some difficulty, and a decision was made to implant the perceval pvs27 (xl size).Pinwheeling was noticed, but the gradient was fine and the patient came off bypass smoothly this time.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model# icv1210, serial# (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# icv1210 (pvs25) perceval heart valve at the time of manufacture and release.Since the device was discarded, no further investigation is possible at this time.However, based on the information available, the root cause of the event can be reasonably traced to the device mis-sizing.Updated fields: b4, b5, f7, f10.

Event Description

On (b)(6) 2020, a patient was intended to received a perceval valve as part of an aortic valve replacement.A perceval pvs25 (l size) was initially sized, the white end of sizer passed through the annulus with slight pressure.The xl sizer did not pass through the annulus.A pvs25 was therefore deployed.After the ballooning, the valve appeared well positioned, with the leaflets coapting at same height and the annulus not visible above or below the perceval annular level, thus pvs25 appeared well implanted.The aorta was closed and, after weaning from by-pass, the perfusionist was having trouble getting pressures up - pulmonic pressures and system pressures equalized.Perivalvular leak was noted at the non-coronary cusp and it was noticed that the valve had dislodged and migrated up.No cpr or other manipulation of the heart were reportedly performed after the pvs25 implant.The pvs25 was explanted and after having re-sized the annulus, the xl sizer passed through the annulus with some difficulty.A decision was made to implant the perceval pvs27 (xl size).No further decalcification was performed after the pvs25 explant.Pinwheeling was noticed, but the gradient was fine and the patient came off bypass smoothly this time.The patient remained stable during the procedure (45 min of cross-clamp time added), and is currently doing well, stable.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 10146661
• MDR Text Key: 199069867
• Report Number: 1718850-2020-01094
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)220724
• 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: 05/11/2020,07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2022
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/14/2020
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2020
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention