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

Model Number PVF-S

Device Problem Perivalvular Leak (1457)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : the valve was discarded by the site.

Event Description

On (b)(6) 2023, a perceval plus valve size s was implanted.Reportedly, pvl was noted after de-clamp and the valve was explanted.No further information provided at this time.

Manufacturer Narrative

The manufacturing and material records for the perceval plus heart valve, model#: f-s, s/n#: (b(6), as they pertain to the reported event, were retrieved and reviewed by a manufacture¿s quality engineering.The results confirmed that this valve satisfied all material, visual and performance standards required for a (model #pvf-s) perceval plus heart valve at the time of manufacture and release.The manufacturer attempted to retrieve further information regarding the event, but no further information was provided, despite manufacturer's multiple attempts.Based on the limited information available, the definitive root cause of the reported event cannot be established at this time.However, from the document review performed, no manufacturing deficiencies were noted.Should further information be received in the future, a follow up report will be provided.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 17140256
• MDR Text Key: 317298481
• Report Number: 3004478276-2023-00156
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000795
• UDI-Public: (01)00896208000795(240)PVF-S(17)260616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• 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,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVF-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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