MAUDE Adverse Event Report: Corcym S.r.l. Perceval Plus Sutureless Aortic Heart Valve; Tissue Heart Valve

Model Number	PVF-XL
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	08/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified of a pacemaker implant involving a perceval plus heart valve through mantra study.Based on the information available, on (b)(6) 2026, a perceval plus heart valve size xl was implanted in a patient.On (b)(6)2026 , the patient experienced complete atrioventricular block.As such, a decision was made on (b)(6) 2026 to implant a permanent pacemaker.This procedure was done on (b)(6) 2026.The outcome has been reported as recovered/resolved w.Sequelae.The patient's clinical history included: coronary artery disease; diabetes mellitus: type ii, non-insulin dependent; dyslipidemia; systemic hypertension; tobacco history: previous; other disease: iron-deficiency anemia, chronic pancreatitis, moderate pericardial effusion; and nyha class ii.
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.From the document review performed, no manufacturing deficiencies were noted.Conduction disorders are common in patients with aortic valve diseases.As a result, it is common for patients to receive permanent pacemaker implantation after aortic valve replacement.Risk factors include preexisting conducting disease and preoperative aortic regurgitation.This event is, therefore, a known, inherent risk of the procedure, and it is listed among the potential adverse events in the perceval plus ifu.Should further information be received in the future, a follow up report will be provided.

• Brand Name: Perceval Plus Sutureless Aortic Heart Valve
• Common Device Name: Tissue Heart Valve
• Manufacturer (Section D): Corcym S.r.l.; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): Corcym Canada Corp.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 50941880
• Report Number: 3004478276-2026-00169
• Device Sequence Number: 13136263
• Product Code: LWR
• UDI-Device Identifier: 08022057015396
• UDI-Public: (01)08022057015396(240)PVF-XL(17)300214
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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-XL
• Device Catalogue Number: PVF-XL
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2026
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 145 LB