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

Model Number PVF-XL

Device Problem Leak/Splash (1354)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text: still implanted.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 331864911
• Report Number: 3005687633-2024-00096
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 08022057015396
• UDI-Public: (01)08022057015396(240)PVF-XL(17)251123
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 02/07/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• 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): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG