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

Model Number PVS23

Device Problem Leak/Splash (1354)

Patient Problem Aortic Regurgitation (1716)

Event Date 08/14/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 a patient was intended to receive a perceval sutureless aortic heart valve pvs23 as part of an avr.After declamping and after the perceval valve pvs23 was indwelled, regurgitation was observed from nadir to center of the lcc, so clamping was performed again.The valve was removed and a new perceval valve was indwelled.The procedure was finished without problems.Extended procedure time was 40 minutes.Total cross-clamping time was 111 minutes.

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 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.

Manufacturer Narrative

The manufacturer attempted to retrieve further event details however no further information was received.The valve pvs 23/m was returned to livanova for evaluation.A preliminary visual inspection was performed in order to record the gross appearance of the returned valve in its as received conditions.Photographs of the device were taken during this step.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.The visual inspection performed on the returned prosthesis confirmed the absence of pre-existing the returned valve was received in the plastic jar of the original packaging and appeared in general good storage conditions.After decontamination, the valve was visually inspected without highlighting elements of non-conformity, according to the specifications.Hydrodynamic testing was conducted on the returned pvs 23/m.The effective orifice area (eoa) at 70 bpm, 5 l/min of cardiac output and mean aortic pressure of about 100 mmhg is 2.36 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 5.3% 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 both normotensive and hypotensive conditions.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device because no regurgitation and no open/close anomalies were observed during the functional test under hydrodynamic testing conditions.Base don the limited information and the investigation results identifying no device related issues the root cause is deemed to be cause not established.

• 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: 10525585
• MDR Text Key: 206739436
• Report Number: 3004478276-2020-00186
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)230301
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 55