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

Model Number PVS23

Device Problems Calcified (1077); Insufficient Information (3190)

Patient Problems Aortic Valve Stenosis (1717); No Information (3190); Heart Failure/Congestive Heart Failure (4446)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

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)(4) 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.The explanted valve is presently being retained at the hospital, but it was flagged as available for return.Thus, further investigation will be performed once returned.The manufacturer is presently retrieving additional information on the event and will provide an update once further information is received.

Event Description

On (b)(6) 2016, a perceval valve pvs23 was implanted in aortic position.It was reported that the surgeon explanted the valve on (b)(6) 2020.No further details about the event or the patient history is provided at this time.

Event Description

On (b)(6) 2016, a perceval valve pvs23 was implanted in aortic position.It was reported that the surgeon explanted the valve on (b)(6) 2020.The manufacturer received additional information confirming that the patient re-presented with severe symptomatic aortic stenosis this year (i.E.2020).The patient developed heart failure of the prosthetic valve developing severe symptomatic aortic stenosis and the had an aborted tavi on (b)(6) 2020 due to high risk of rca/left main occlusion.It was also noted that the patient developed transient complete heart block (pre-existing left bundle branch block), but did subsequently recover by the end of the procedure.Thus, a treatment by surgery was deemed required.At the time of the re-intervention, the aortic valve prosthesis was very heavily adherent to the aortic wall especially in the non coronary sinus valsalva.The pvs23 valve was also found heavily calcified and would not open or closed very well.After the perceval explant, a patch repair of the coronary sinus was performed.The patient ultimately received a perimount 21mm valve.An aortic root enlargement was also performed.The patient tolerated the procedure well and was moved to the icu intubated and hemodynamically stable.On (b)(6) 2020, the patient received a pacemaker due to complete heart block, no complications reported.The patient was discharged on (b)(6) 2020.The patient previous medical history includes hypertension and diabetes (insulin requiring).

Manufacturer Narrative

The device involved in the reported event was returned to the manufacturer for investigation.The returned prosthesis was received in an altered state.The valve appeared deformed and the pericardium rigid.The presence of leaflet calcifications was confirmed by both histopathology and x-ray analysis.The stent and the skirt of the prosthesis were covered by fibrous pannus that on the inflow side slightly protruded 2mm into the lumen, narrowing the annulus.The histological analysis confirmed the presence of inflammatory cells and red blood cells.Small thrombus depositions were detected on both prosthetic sides.Reddish areas due to coagulated blood entrapment were present on all surfaces.The collagen bundles of the pericardium were disrupted, defibrated and homogenated.Pericardial delaminations were also detected.There was no evidence of endocarditis in the returned valve.Based on the information available and investigation performed, it can be concluded that the leaflets calcification, detected with visual, x-ray and histological analyses, caused stiffening and led to progressive valve stenosis.Pannus tissue overgrowth into the inflow lumen and on the free edges of leaflets also contributed to valve stenosis.As reported in the scientific literature, structural dysfunction is the major cause of failure of bioprosthetic heart valves and the principal underlying pathologic process is cuspal calcification.It is possible that the patient¿s clinical history and risk factors (previous aortic valve stenosis, hypertension and diabetes-insulin reuquiring) may have contributed to the structural valve deterioration observed in this perceval s valve.It should be noted that structural valve deterioration is listed as a possible adverse event in the perceval ifu valve.The event is therefore a known inherent risk of the device.

• 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: 11060454
• MDR Text Key: 223776753
• Report Number: 1718850-2020-01219
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)181130
• 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: 11/26/2020,02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/13/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2020
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR