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

Model Number	PVS27
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/16/2020
Type of Reportable Event	Death
Event or Problem Description
Manufacture was informed the event through device tracking database.Based on the information received from patient implant form, a perceval valve size 27 was implanted in the patient on (b)(6) 2020.Reportedly, patient passed away on (b)(6) 2020.No further information available at this time.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h6.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.Based on the information available, the definitive root cause of the reported event cannot be established, however, from the document review performed, no manufacturing deficiencies were noted.It is possible that the cause of the death was related to the patient's clinical history and risk factors, but it cannot ultimately be confirmed.
Event or Problem Description
Manufacture was informed the event through device tracking database.Based on the information received from patient implant form, a perceval valve size 27 was implanted in the patient on (b)(6) 2020.Reportedly, patient passed away on (b)(6) 2020.Based on the further information received, the soft, pliable annulus was sized to perceval xl.Reportedly, the valve was deployed well in excellent location.Reportedly, the valve showed excellent function with echo and procedure was completed with no issue.Based on the information available, prior to the surgery patient was diagnosed with myocardial infarction, abnormal ekg, acute urinary retention, and etc.Patient also had a heart block with pacer.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 20434103
• Report Number: 3004478276-2024-00177
• Device Sequence Number: 20937685
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)211104
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2024

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 Expiration Date: 11/04/2021
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2018
• 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: Death
• Patient Age: 79 YR
• Patient Sex: Unknown