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

Model Number	PVF-XL
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed that a perceval valve size xl was implanted on (b)(6) 2023.Reportedly, sizing and positioning was good.No positioning difficulties were noted.During the inspection, no fluttering or sign of oversizing on the leaflet were noted.After de-clamp, a severe central leak was detected.As such, the valve was explanted, and a magna valve size 27 was successfully implanted in the patient instead.It was reported that after explanation, visual inspection was performed, and it was mentioned that one of the leaflets (non-coronary leaflet) is asymmetric.Based on the further information received, a little abnormal geometry was noted in the patient's annulus.No further information is available.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval plus heart valve, model#: pvf-xl, 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 satisfied all material, visual, and performance standards required for a (model # pvf-xl) perceval plus heart valve at the time of manufacture and release.Steady flow test review was also performed.The images demonstrated 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.The device 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, except for some plies in the leaflets.The hydrodynamic testing was conducted on the pvf-xl was performed.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean backpressure of 100 mmhg is 3.74 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 7.0 % and it is below the requirement of iso 5840:2021 (rf% < 15%) for a prosthesis of equivalent tad.No anomalies were observed during valve closing phase under both normotensive and hypotensive conditions.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 detected.The reason for this anomaly could be attributable to some manipulation that occurred at the implant/explant or to some deformation caused by a peculiar anatomical geometry producing this effect, which is visible in hypotensive conditions, but not in normotensive conditions.In any case, the observed feature is totally unrelated to the coaptation (the issue complained by the customer) which, on the contrary, appears complete in both 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 issues were not observed during the investigation carried out (i.E.Hydrodynamic test).Furthermore, from the document review performed, no manufacturing defects were noted.As reported, it is possible that slight abnormality in patient annulus was contributed to this event, but this cannot ultimately be confirmed.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: 18514958
• Report Number: 3004478276-2024-00110
• Device Sequence Number: 7188091
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)270603
• 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): 03/01/2024

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-XL
• Device Catalogue Number: PVF-XL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2023
• 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 Sex: Male