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

Model Number	PVS27
Medical Device Problem Codes	Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve, model #icv1211, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by the manufacturer's quality engineering.The results confirmed that the valve and nitinol stent component satisfied all material, visual, and performance standards required for a model #icv1211 perceval heart valve at the time of manufacture and release.Since the device was discarded, no further investigation can be performed at this time.Based on the information available and medical judgment received, the root cause of the reported failure to implant due to perivalvular leak can be traced to a device mis-sizing.
Event or Problem Description
The manufacturer was informed on this event through the patient tracking department.Based on the information reported on the patient implant form, a perceval valve model pvs27 was implanted and explanted on (b)(6) 2020.No allegation of a device malfunction nor of a serious injury was received from the site regarding the reported event.The manufacturer obtained the following additional information on the event.The patient was referred for an elective aortic valve replacement due to aortic valve stenosis.The aortic valve was tricuspid in nature with severe leaflet and moderate annular calcifications.The annulus was measured at around 25mm and a perceval xl was selected.During reperfusion, it was apparent that there was a moderate to severe amount of perivalvular aortic valve regurgitation in the region of the left coronary sinus.It was therefore decided to remove the perceval valve and to insert a sutured valve (carpentier edwards perimount magna ease 25mm).The patient has done well postoperatively.Based on the medical judgment on the event, the main problem was a large annular diameter.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 12251547
• Report Number: 1718850-2021-01135
• Device Sequence Number: 11682749
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)221017
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2021
• Report Date (Section F): 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2022
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention