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

Model Number PVF-XL

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/11/2022

Event Type  Injury  

Manufacturer Narrative

A complete manufacturing and material records review for the component has been performed.The results confirmed that the component satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the information received, the cause of the reported event was attributed to the mis-sizing (reportedly, the valve was too small).No device malfunction or adverse event on the patient has been reported and patient had a good outcome.Furthermore, from the document review performed, no manufacturing deficiencies were identified.As such, no further investigation is warranted.Should further information be received in the future, the manufacturer will provide a follow up report.

Event Description

The manufacturer was informed of this event through patient tracking database.Based on the information on the patient's implant from, pvf-xl which was implanted on (b)(6) 2021 was explanted on (b)(6) 2022, and cna27 was implanted in the patient as a replacement.Based on the information received, the valve was explanted due to the perivalvular leak and it was determined to be too small.As reported, during the initial implant it was thought that xl could be used although it was on the upper end of the valve¿s acceptable range.The patient wasn¿t doing well upon follow up and a leak was found around the valve.Thus, the valve was explanted.The perceval plus valve was removed and a crown valve was implanted without any incident.Patient¿s recovery went well.The manufacturer was informed that no further information will be received regarding this event at this time.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 14359125
• MDR Text Key: 291405556
• Report Number: 3004478276-2022-00147
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)221217
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150011/S013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2022
• Device Model Number: PVF-XL
• Device Catalogue Number: PVF-XL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male