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

Model Number	PVS23
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Rupture (2208)
Date of Event	04/08/2024
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2024, the perceval pvs23/m valve was implanted in a patient with type1 bicuspid valve.The surgery was mics avr, and aortic root rupture was noted after de-clamped.As such, they clamped again, repaired the hole with a pericardial patch and de-clamped again, but the bleeding did not stop and was re-clamped.The valve ring and basal half were reconstructed with artificial vessels and re-sized, but the white head of medium sizer did not pass through.As such, they downsized and implanted a pvs size 21/s no l.Reportedly, no leak was noted after implant.Based on the further information received, patient remained stable throughout the surgery.Reportedly, patient eventually passed away on (b)(6) 2024.Based on the medical judgment received, it is possible that the damage to the aortic root around the top of the rcc occurred be by cusa.
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 observing any macroscopic anomalies and/or pre-existing defects according to the specifications.The replication of collapsing phases was performed using the returned valve pvs 23/m and a demo accessory kit.No problems were encountered in the collapsing phase which has been completed with a good result.During the simulation of the valve deployment in silicon aortic root #21, no problems were encountered during the ballooning phase: the sealing at the annulus level is guaranteed; thus, the valve remained fixed within the annulus.Then, inserting some water in the aortic roots from the outflow side, no paravalvular leaks was observed during the simulations.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.Frome the information received, the anatomical structure both from a geometric (bicuspid) and consistency point of view of the aortic wall, required significant actions which led to a change in the choice of size to implant.Furthermore, based on the medical judgment received, it is possible that the damage to the aortic root around the top of the rcc occurred be by cusa.As such, the cause of the reported event could possibly be related to patient anatomy and surgery.It should also be noted that as reported in the perceval ifu, "data from clinical or in vitro testing are not available to establish the safe use of the perceval valve in patients with congenital bicuspid aortic valve.Therefore, careful consideration of its use is recommended in such cases, especially when the depth of the 2 sinuses in the lvot is unequal.".

• Brand Name: PERCEVAL 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: 19263491
• Report Number: 3004478276-2024-00135
• Device Sequence Number: 16789880
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)260907
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• 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): 06/13/2024

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 Expiration Date: 09/07/2026
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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: Death
• Patient Age: 74 YR
• Patient Sex: Female