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

Model Number PVS23

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/12/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval valve model pvs23 was attempted to be implanted.The device was explanted intraoperatively due to massive central leakage.After inspection, the surgeon saw an irregularity in the leaflet connection to one of the struts.The second implant with a new m-valve was good.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model#: icv1209 , s/n#: (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The review performed included a review of the steady flow test performed at the time of manufacture.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 device was returned to the manufacturer on 12 mar 2021.As such, further testing on the devices are being performed and an update to this reporting activity will be provided upon completion of the investigation.

Manufacturer Narrative

The event, related to the perceval heart valve prosthesis, pvs-m occurred on (b)(6) 2021, at ¿(b)(6) hospital¿ ¿ (b)(6) ¿ the netherlands, during the implantation procedure.It was reported, on (b)(6) 2021, a perceval valve model pvs 23/m was attempted to be implanted.The device was explanted intraoperatively due to massive central leakage.After inspection, an irregularity in the leaflet connection to one of the struts was detected.The second implant with a new valve size m was good.The valve pvs 23/m was returned to livanova for evaluation.Review of the data filed in the device history record of the returned perceval heart valve sn (b)(6) , confirmed that the valve satisfied all material, dimensional, and performance standards required for a perceval valve pvs 23/m at the time of manufacture and release.A preliminary visual inspection was performed in order to record the gross appearance of the returned valve in its ¿as received¿ conditions.The returned pvs 23/m was received contained in the original plastic jar.The returned prosthesis valve was received in general good conditions with the pericardium slightly darker than normal and with blood and organic residual.After decontamination, the valve was visually inspected without highlighting elements of non-conformity, according to the specifications.The effective orifice area (eoa) at 70 bpm, 5 l/min of cardiac output and mean aortic pressure of about 100 mmhg is 2.42 cm2, well above the iso 5840 minimum requirement 1.25 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction is 5.5% and it is below the requirement of iso 5840 (rf% = 10%) for a prosthesis of equivalent tad.No anomalies were observed during the open/close cycle in normotensive conditions and hypotensive conditions.No anomalies were observed during the open/close cycle.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic in the involved device because the claimed issues were not observed during the investigation carried out (i.E.Hydrodynamic test) in both normotensive and hypotensive conditions.The root cause is thus no device problem found, but the cause of the central leak cannot be established at this time.

• 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: 11325784
• MDR Text Key: 234500463
• Report Number: 3004478276-2021-00124
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)231205
• 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: 04/29/2021

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
• Device Expiration Date: 12/05/2023
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 03/12/2021; 04/14/2021
• Supplement Dates FDA Received: 04/07/2021; 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention