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

Model Number	PVS23
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/13/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer was informed of a patient's death through the japan perceval heart valve study database.As reported in the database, a perceval s valve, size 23 was implanted on (b)(6) 2019 with median sternotomy surgical approach.The condition of the aortic valve was tricuspid, the aortic annulus was calcified, and the ascending aorta was normal.The operation was successful, and the patient was discharged on (b)(6) 2019; at discharge the patient was nyha ii, the cardiac rhythm was atrial fibrillation and the echocardiografic exam did not show any regurgitation.The patient underwent an laa amputation procedure as atrial fibrillation treatment on (b)(6) 2019, before valve surgery.Reportedly, patient died on (b)(6) 2023 and the cause is unknown.Patient's clinical history included atrial fibrillation; stroke on (b)(6) 2019, and was nyha class ii.
Additional Manufacturer Narrative
H3 other text : unknown disposition.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve and stent, model # icv1209, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a (model # icv1209) perceval heart valve at the time of manufacture and release.Based on the limited information available, the definitive root cause of the reported event cannot be established since cause of the death is unknown.However, from the document review performed, no manufacturing deficiencies were noted.Should further information be received in the future, a follow up report will be provided.

• 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: 18914246
• Report Number: 3004478276-2024-00124
• Device Sequence Number: 17865687
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)211128
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/17/2024

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: 11/28/2021
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• 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: 02/16/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• 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: Female
• Patient Weight: 52 KG