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

Model Number	PVF-XL
Medical Device Problem Codes	Incomplete Coaptation (2507); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer was informed that percival plus size xl was implanted on (b)(6) 2024 but was explanted intra-operatively since leaflet did not function.Based on the further information received, valve leaflets didn¿t close after valve was implanted.Reportedly, no malfunction with the device was noted prior to this event.Based on the information received from the site, they think that patient sized out not enabling the valve to collapse enough to make leaflets close.No further information is available at this time.
Additional Manufacturer Narrative
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 is performing investigation on the returned device.A follow up report will be provided upon completion of this investigation and/or receipt of any further information.
Additional Manufacturer Narrative
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.Steady flow test review was also performed.Images demonstrate the acceptable opened and closed leaflet performance of the perceval pvf-xl sn#: (b)(6).No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection defined in the dedicated procedure at the time of release.Device was returned to the manufacturer.After decontamination, the valve was visually inspected without detecting macroscopic anomalies and/or pre-existing defects according to specifications.The hydrodynamic testing was conducted on the pvf-xl.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean backpressure of 100 mmhg is 4.10 cm2, above the iso 5840:2021 minimum requirement 1.75 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction is 6.6 % and it is below the requirement of iso 5840:2021 (rf% < 15%) for a prosthesis of equivalent tad.No anomalies were observed during valve opening and closing phase under normotensive and hypotensive conditions.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device because the claimed issue (insufficiency) was not observed during the investigation carried out (i.E.Hydrodynamic test).Furthermore, from the document review performed, no manufacturing deficiencies were noted.Based on the judgement received, the cause of the reported event was probably related to mis-sizing.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC 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: 20252766
• Report Number: 3004478276-2024-00170
• Device Sequence Number: 12928528
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)270624
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150011S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PVF-XL
• Device Catalogue Number: PVF-XL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 09/28/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2023
• 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: 84 YR
• Patient Sex: Unknown