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	01/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer was informed of the event through device tracking department.Based on the information on patient registration form, on (b)(6) 2021, pvs27 was explanted intra-operatively.Reportedly, patient is now deceased.No further information has been received from the site about any device malfunction nor patient injury.
Additional Manufacturer Narrative
Updated fields: b4, 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.Manufacturer attempted to follow up with the site, but no further information has yet been received, despite multiple attempts of follow up.Since limited information is available, the definitive root cause of the reported event cannot be established at this time.However, form the document review performed; no manufacturing deifies were noted.Should further information be rein 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: 20518298
• Report Number: 3004478276-2024-00181
• Device Sequence Number: 8638965
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)230129
• 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: 2021
• Device Explanted Year: 2021
• 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): 11/27/2024

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: 01/29/2023
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2020
• 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: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Unknown