MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVF-XL
Medical Device Problem Codes	Incomplete Coaptation (2507); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.A follow up report will be provided upon receipt of the device or any new information.
Event or Problem Description
On (b)(6) 2022, after implanting perceval plus valve pvf-xl through full sternotomy, central leak was detected in the echo imaging and it was discovered that the leaflets were not coaptating.Consequently, it was decided to explant and re-implant the valve.However, despite repeating the procedure, central leak in echo imaging persisted, leading to removal of the valve.Ultimately, edwards inspiris resilia valve 25 mm was utilized to complete the procedure.No adverse patient effects were reported.Reportedly, upon examining the explanted pvf valve, it was discovered that one of the leaflets was shorter than the others.Based on the further information received, no pvf valve malfunction or mis-sizing were identified prior to the event.The procedure was a combined coronary artery bypass grafting and aortic valve replacement (cabg-avr), and the patient geometries were not considered abnormal.The procedure was delayed by one hour, but patient remained in stable condition throughout the procedure.There was no additional debridement or annular restructuring performed prior to the second valve implant.
Additional Manufacturer Narrative
The valve was returned to the manufacturer.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean backpressure of 100 mmhg is 3.84 cm2, above the iso 5840:2021 minimum requirement 1.70 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction is 5.4 % and it is below the requirement of iso 5840:2021 (rf% < 15%) for a prosthesis of equivalent tad.No anomalies were observed during the open/close cycle in both normotensive conditions regarding the total and full coaptation of the leaflets.In hypotensive conditions, on the other hand, a not complete opening of the leaflets was found.This is in contrast with what is documented by the images retrieved on the dhr relating to the tests carried out for the release of the product.The reason for this difference is reasonably attributable to the imperfect condition of the prosthesis at the time of receipt in the laboratory.In any case, the observed feature is totally unrelated to the reported coaptation issue which, on the contrary, appears complete and totally comparable with the dhr image.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device because the claimed issues were not observed during the investigation carried out (i.E., hydrodynamic test).Furthermore, from the document review performed.No manufacturing deficiencies were noted.As such, the cause of the event cannot be traced to the device.Should further information be received in the future, a follow up report will be provided.
Additional Manufacturer Narrative
A follow up report will be provided upon completion of device investigation.
Additional Manufacturer Narrative
A follow up report will be provided upon receipt of the device or any new information.
Event or Problem Description
On (b)(6) 2022, after implanting perceval plus valve pvf-xl through full sternotomy, central leak was detected in the echo imaging, and it was discovered that the leaflets were not coaptating.Consequently, it was decided to explant and re-implant the valve.However, despite repeating the procedure, central leak in echo imaging persisted, leading to removal of the valve.Ultimately, edwards inspiris resilia valve 25 mm was utilized to complete the procedure.No adverse patient effects were reported.Reportedly, upon examining the explanted pvf valve, it was discovered that one of the leaflets was shorter than the others.Based on the further information received, no pvf valve malfunction or mis-sizing were identified prior to the event.The procedure was a combined coronary artery bypass grafting and aortic valve replacement (cabg-avr), and the patient geometries were not considered abnormal.The procedure was delayed by one hour, but patient remained in stable condition throughout the procedure.There was no additional debridement or annular restructuring performed prior to the second valve implant.Based on the further information received, cabg procedure was performed prior to the valve implant.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 17011100
• Report Number: 3005687633-2023-00115
• Device Sequence Number: 18051595
• Product Code: LWR
• UDI-Device Identifier: 08022057015396
• UDI-Public: (01)08022057015396(240)PVF-XL(17)251124
• 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,Followup,Followup
• Report Date (Section B): 08/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2025
• Device Model Number: PVF-XL
• Device Catalogue Number: PVF-XL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 05/25/2023; 06/29/2023; 08/01/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/20/2023; 07/27/2023; 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• 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 Sex: Unknown