MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVF-L
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the perceval plus heart valve and nitinol stent, model pvf-l, s/n # b22113, as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve and its component satisfied all material, visual, and performance standards required for a model pvf-l perceval plus heart valve at the time of manufacture and release.Based on the available information and since the device was not accessible for testing, it is not possible to draw a definitive root cause on the reported event.However, based on 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 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.
Event or Problem Description
The manufacturer was informed of the following event through mantra study.Based on the information received, a perceval plus sutureless aortic heart valve size l was implanted in the patient through mini sternotomy on (b)(6) 2023.No concomitant procedure was performed.Reportedly, as of (b)(6) 2023, there was a complete heart block requiring permanent pacemaker to be implanted on (b)(6) 2023to resolve the event.Reportedly, tvp placement was also performed on (b)(6) 2023.As indicated in the study database, patient had a history of infective endocarditis which was resolved; congenital septal defect, heart murmur, bicuspid av, av stenosis, and nyha class ii.

• 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: 16685840
• Report Number: 3019892983-2023-01010
• Device Sequence Number: 12569219
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVF-L(17)261007
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2023
• Report Date (Section F): 03/08/2023

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-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/08/2023
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2023
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 79 KG