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

Model Number	PVF-M
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the device involved in this event, as they pertain to the reported issue, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this prosthesis satisfied all required material, visual, and performance standards at the time of manufacture and release.Based on the information available, the definitive root cause of the reported event cannot be established.Based on the information available, the valve remained implanted, only medication dose change was performed, and patient is doing fine now.Reportedly, there is no plan for reintervention at this time.As such, there is no indication of device issue at this time.Furthermore, from the document review performed, no manufacturing deficiencies were noted.Should further information be available in the future, a follow up report will be provided.
Event or Problem Description
The manufacturer was informed of the following event through mantra study database.Reportedly, a perceval plus valve size m was implanted in the patient on (b)(6) 2023.Based on the information received, patient had aortic insufficiency that started on (b)(6) 2024 which required change dose/schedule of medication as well as diagnostic examinations and/or tests.As reported, the patient's clinical history included coronary artery disease; stable angina; myocardial infarction (remote (> 90 days)); left ventricular hypertrophy; ischemic heart failure; arrhythmia (atrial fibrillation); systemic hypertension; dyslipidemia; other neurological dysfunction; pulmonary hypertension; resolved malignancy; and covid-19.Furthermore, percutaneous coronary intervention: stenting; and aortic valve replacement: biological 2018 were also reported, and nyha class was iv.Based on the further communication received, patient was discharged and is feeling better.There is no plan for the re-intervention and regular follow ups will be performed.

• Brand Name: PERCEVAL PLUS 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: 19094346
• Report Number: 3019892983-2024-01004
• Device Sequence Number: 7344346
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)270421
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2024
• Report Date (Section F): 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PVF-M
• Device Catalogue Number: PVF-M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/13/2024
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2024
• 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: Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 64 KG