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

Model Number	PVF-S
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Manuacturer was informed that on 22 nov 2023, a perceval plus valve size s was implanted and upon coming off of pump, valve appeared to have buckled onto itself in the echo.It was reported that the valve was too large for the annulus.As such, the valve was explanted, and a stented valve was implanted.Reportedly, patien's annulus was 19.8 per the ct analysis report.As reported, patient ultimately was placed on ecmo.No further information is available.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval plus heart valve and stent, 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 satisfied all material, visual, and performance standards required for a (model # pvf-s) perceval plus heart valve at the time of manufacture and release.The valve has been returned to the manufacturer.After decontamination, the valve was visually inspected and, except a slight ovalization / deformation, no macroscopic anomalies, and/or pre-existing defects were observed.The replication of collapsing phases was performed using the returned valve pvf-s and a demo accessory kit, in order to attempt to reproduce the reported event.No problems were encountered in the collapsing phase, and the replication has been completed without problem.No problems were encountered during the deployment in silicon aortic roots #21, and the ballooning phase, and the sealing at the annulus level is guaranteed as visible in attached pictures thus, the valve remained fixed within the annulus.Then, inserting some water in the aortic roots from the outflow side, no paravalvular leaks were observed during the simulation.Considering the static conditions of the test, the water level remained stable under the leaflets free edge.Based on the performed analyses, it is possible to exclude the relationship between the reported issue and the returned device quality.Furthermore, from the document review performed, no manufacturing deficiencies were noted.Based on the information provided (i.E., ''the valve was too large for the annulus''), the cause of the reported event is most probably related to oversizing.

• 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: 18387805
• Report Number: 3004478276-2023-00218
• Device Sequence Number: 14127987
• Product Code: LWR
• UDI-Device Identifier: 00896208000795
• UDI-Public: (01)00896208000795(240)PVF-S(17)270317
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/16/2024

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-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• 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: 11/26/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• 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: Unknown