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

Model Number	PVF-S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of the following event through device tracking department.Based on the information in patient registration forms, on 19 april 2023, patient received a perceval plus valve size s.Reportedly, on 10 may 2023, the device was replaced with another similar device pvf-s.No indication of device malfunction has been received from the site.The manufacturer was informed that no further information is available.
Additional Manufacturer Narrative
H3 other text : unknown disposition.
Additional Manufacturer Narrative
Manufacturer attempted to follow up with the case but was informed that no further information is available regarding this case.The manufacturing and material records for the perceval plus heart valve, model # pvf-s 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 # pvf-s) perceval plus heart valve at the time of manufacture and release.Based on the limited information available and since the device was not returned to the manufacturer for further investigation, the definitive root cause of the reported event cannot be established at this time.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 PLUS 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: 18234639
• Report Number: 3004478276-2023-00207
• Device Sequence Number: 11569594
• Product Code: LWR
• UDI-Device Identifier: 00896208000795
• UDI-Public: (01)00896208000795(240)PVF-S(17)240731
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011/S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/30/2024

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: 07/31/2024
• Device Model Number: PVF-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: No
• 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: 11/01/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• 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: 69 YR
• Patient Sex: Female