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

Model Number	PVF-L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed that on (b)(6) 2023, a perceval plus valve size l was attempted to be implanted in a patient.Reportedly, when they went off pump, there was no heartbeat.As such, they went back on pump, explanted the valve and replaced it with intuitive 23mm valve.However, off pump there was still no heartbeat.Thus, the patient was air flighted to another facility.No further information is available at this time.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h6.The device has been returned to the manufacturer and further investigation is ongoing.Furthermore, manufacturer is retrieving and reviewing the manufacturing documents.A follow up report will be provided upon completion of investigation or receipt of any further information.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval plus heart valve, model # pvf-l, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacture¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a (model # pvf-l) perceval plus heart valve at the time of manufacture and release.Steady flow test review was also performed.The images demonstrate the acceptable opened and closed leaflet performance of the perceval pvf-l 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.Conclusion will remain the same.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval plus heart valve, model # pvf-l, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacture¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a (model # pvf-l) 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 without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.Functional test was performed.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean backpressure of about 100 mmhg is 3.39 cm2, well above the iso 5840 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 4.2 % and it is below the requirement of iso 5840 (rf% < 15%) for a prosthesis of equivalent tad.No anomalies were observed during the whole cardiac cycle under 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 no regurgitation and no open/close anomalies were observed during the functional test under hydrodynamic testing conditions per iso 5840:2021 minimum requirements.Furthermore, from the document review performed, no manufacturing deficiencies were noted.As such, the cause of the reported event cannot be traced to the device.Should further information be received in the future, a follow up report will be provided.

• Brand Name: PERCEVAL PLUS SUTRUELESS 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: 18136624
• Report Number: 3004478276-2023-00197
• Device Sequence Number: 12758080
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVF-L(17)270406
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/22/2024

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
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/21/2023; 12/20/2023; 01/22/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/19/2023; 01/19/2024; 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• 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