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 Codes	Atrial Fibrillation (1729); Heart Block (4444)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
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) 2024.Based on information received, patient had chb with afib on (b)(6) 2024.The patient needed a permanent pacemaker which was implanted on (b)(6) 2024 to resolve the issue.As reported, the patient's clinical history included coronary artery disease; arrhythmia: afib; systemic hypertension; diabetes mellitus: type ii, insulin dependent; dyslipidemia; renal insufficiency / renal disorder (dialysis ongoing); percutaneous coronary intervention (stenting 2019); and was in nyha class iii.Based on the information available, prior and concomitant anticoagulant/antiplatelet medications are warfarin, eliquis and aspirin.

• 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: 18861785
• Report Number: 3019892983-2024-01001
• Device Sequence Number: 8239312
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)270421
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2024
• Report Date (Section F): 02/07/2024

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
• Distributor Facility Aware Date: 02/07/2024
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2024
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 114 KG