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

Model Number	PVF-L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, perceval plus size l was attempted to be implanted.Reportedly, the device was collapsed with relyon system without any issues.Guiding sutures were placed in eyelets and valve was deployed into place without issue.Position of the valve was inspected, and no issues were detected.Thus, the valve was ballooned for 30s at 4 atm¿s.Then, aorta was closed, and they began to perform the cabg.Once cabg was performed clamp was removed, and the refill process was started.Patient required 2-3 shocks to get a rhythm.They de-aired with a 19ga needle.No leaks or ar was observed in the echo.All of the sudden surgeon called for a ballon pump and the ballon pump was inserted into the patient's rt groin.At this point, significant regurgitation was noted.The reason for this regurgitation was unknown since before inserting the pump, no leakage was present.As such, they decided to re-clamp and replace the perceval with a 23 mm inspiris valve.Based on the further information received, no malfunction with the device was noted, and patient's outcome was good.Reportedly, annulus was measured as 22.0mm, stj was 25.6, and ratio was 1.16.
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.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-l.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean backpressure of 100 mmhg is 3.31 cm2, above the iso 5840:2021 minimum requirement 1.45 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction is 4.7 % 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.This is aligned with the information received from the field (i.E., " no malfunction with the device was noted").As such, cause of the reported event cannot be traced to the device.

• 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: 19579591
• Report Number: 3004478276-2024-00143
• Device Sequence Number: 17138866
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVF-L(17)270309
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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): 07/19/2024

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-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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: 79 YR
• Patient Sex: Male