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

Model Number PVS25

Device Problem Leak/Splash (1354)

Patient Problem Aortic Regurgitation (1716)

Event Date 08/24/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 a patient received a perceval pvs25 sutureless aortic heart valve as part of an avr.No issues were identified with the indwelled position and shape, the aorta was closed and checked via transesophageal echo, but regurgitation was observed in area from rcc to ncc.Since no indwelling position misalignment or valve opening/closing abnormalities were observed on the short-axis image, it was decided to perform a re-implantation.When the perceval was exposed, the annulus distortion and leaflet distortion were checked, but they could not be confirmed.Some portion of the valve appeared small.The valve was analyzed after explant and a section of leaflet at the cusp seemed to be shorter.When sizing was performed again and another perceval (same size, l) was indwelled, the implant was successful without any problems.Extended extracorporeal circulation time was 20 minutes.No problem observed after the procedure.The patient is currently being followed.

Manufacturer Narrative

The device was returned for analysis.The returned valve prosthesis appears in general good storage conditions.The visual inspection performed on the returned prosthesis confirmed the absence of pre-existing defects.The leaflet height verification confirmed the compliance of this dimensional parameter.The go-no go test confirmed the absence of dimensional irregularity.The deployment simulations and the static leak tests, performed on the returned valve, did not highlight evidence of paravalvular leaks.Based on the performed analyses, it is possible to exclude any relationship between the device and the reported issue as no device related malfunctions or abnormalities were detected.The manufacturer is presently performing a review of the device history records to ensure the device met all required standards at the time of manufacture and release.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1210, 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 #icv1210) perceval heart valve at the time of manufacture and release.Based on the performed analyses, it is possible to exclude any relationship between the device and the reported issue as no device related malfunctions or abnormalities were detected.The returned prosthesis satisfied all the manufacturing requirements at the time of manufacture and release.

• 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: 10578180
• MDR Text Key: 208312818
• Report Number: 1718850-2020-01150
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2020,12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2020
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 62