MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL PLUS SUTRUELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVF-XL
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text: still implanted.
Event or Problem Description
The manufacturer was informed of the following event through mantra study database.Reportedly, a perceval plus valve size xl was implanted in the patient on (b)(6)2022.Based on the information received, patient had paravalvular regurgitation that started on (b)(6) 2023.The patient was hospitalized for evaluation of pvl identified in tte conducted on (b)(6) 2023, and discharged after examination.The event severity was considered mild, and no action has yet been taken.As reported, patient's clinical history included angina; systemic hypertension; dyslipidemia; obesity; tympanites (50 years ago); and patient was nyha class iii.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the sutureless valve pvf-xl has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.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.Based on the information available, no action has yet been taken and the valve remained implanted.As such, further investigation on the actual device cannot be performed either.Should further information be received in the future, a follow up report will be provided.

• Brand Name: PERCEVAL PLUS SUTRUELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 18439954
• Report Number: 3005687633-2024-00096
• Device Sequence Number: 4681643
• Product Code: LWR
• UDI-Device Identifier: 08022057015396
• UDI-Public: (01)08022057015396(240)PVF-XL(17)251123
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011/S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 11/23/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG