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

Model Number	PVF-M
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the perceval plus heart valve, model pvf-m-ca, 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-m perceval plus heart valve at the time of manufacture and release.The manufacturer is following up to retrieve further information regarding the event.A follow up report will be provided upon receipt of any further information.H3 other text: unknown disposition.
Event or Problem Description
The manufacturer was informed of the following information through device tacking department.Based on the information received from patient registration form, a perceval plus size m was not implanted due to wrong size, and perceval plus s was ultimately implanted.No allegation of any device dysfunction or patient injury has been received from the site.
Additional Manufacturer Narrative
The manufacturer attempted to follow up with the hospital to retrieve further information regarding the case and the valve involved but no information has yet been received, despite manufacturer's multiple attempts of follow up.Based on the information available, the valve was not implanted due to wrong size and a smaller valve was ultimately implanted in the patient.Furthermore, form the document review performed, no manufacturing deficiencies were noted.As such, the cause of the event can reasonably be related to the mis-sizing (use-error).Should further information be received in the future, a follow up report will be submitted.

• 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: 18188260
• Report Number: 3004478276-2023-00201
• Device Sequence Number: 12578875
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)261211
• 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
• 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): 01/24/2024

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 Model Number: PVF-M
• Device Catalogue Number: PVF-M
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2022
• 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: 70 YR
• Patient Sex: Female