MAUDE Adverse Event Report: CORCYM CANADA CORP. 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	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed through the mantra study of a pacemaker implant performed on a patient who had received a perceval valve 10 days earlier.As per information retrieved from the study database, the perceval valve was implanted through median sternotomy and cabg (3 vessels) was performed before perceval implant.The patient¿s native valve was tricuspid, calcified, and exhibited both stenosis and insufficiency due to degenerative aetiology.Patient¿s medical history included dyslipidaemia, systemic hypertension, coronary artery disease treated with ptca in 2020, transient ischemic attack.No conduction disorders were reported.Patient was in nyha class iii.Based on the available information, intermittent third-degree av block arose on day 8 post-surgery, which was addressed with a pacemaker implant 2 days later.The patient was discharged home on (b)(6) 2024.The site assessed the event as probably related to the device and to the initial implant procedure.
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.Since the device is not accessible for testing, the manufacturer couldn't perform further investigation on the prosthesis involved in the reported event.Based on the available information, it is not possible to draw a definitive root cause for the reported event.However, from the document review performed, no manufacturing deficiencies were identified.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, which, based on the available information, was not present though in the medical history of the patient involved in this event, 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 ifu.

• 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
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 20366819
• Report Number: 3004478276-2024-00174
• Device Sequence Number: 12482263
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)280413
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P150011S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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-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: 09/05/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2024
• 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: 78 KG