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

Model Number	PVS21
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed that on (b)(6) 2023, a mics avr surgery using percival hear valve size s was performed and there was no concomitant procedure.Reportedly, after de-clamp during the surgery, moderate pvl was noted between rcc and lcc.As such, it was clamped again, and it was noticed that the position of the inflow ring was slightly above annulus.The device was explanted, and another percival valve size s was implanted instead.Reportedly, no leakage was noted after re-implantation, the surgical time was delayed about 60 minutes due to this event, patient remained stable through the prolongation of surgery, and the outcome of the patient was good.Based on the information received, patient's annulus was 28mm.Reportedly, positioning difficulty was noted during valve implantation.
Additional Manufacturer Narrative
The manufacturing and material records for the percival heart valve and nitinol stent, model #icv1208, s/n # (b)(4), 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 #icv1208) percival heart valve at the time of manufacture and release.A follow up report will be provided upon receipt of the device or additional information.
Additional Manufacturer Narrative
The valve 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 21/s and a demo accessory kit.No problems were encountered in the collapsing phase, and the replication has been completed with a good result.During the simulation of the valve deployment in silicon aortic root #21, no problems was encountered during the ballooning phase: the sealing at the annulus level is guaranteed as visible in the attached pictures; thus, the valve remained fixed within the annulus.Then, inserting some water in the aortic root from the outflow side, no paravalvular leaks were observed during both the simulations.Considering the static conditions of the test, the water level remained stable under the leaflets free edge.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic in the involved device.Furthermore, from the document review performed, no manufacturing deficiencies were noted.Based on the information available, it was noticed that the position of the inflow ring was slightly above annulus.As such, the cause of the reported event can be related to malpositioning.Should further information be received in the future, a follow up report will be provided.

• 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: 16566988
• Report Number: 3004478276-2023-00121
• Device Sequence Number: 17568728
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)250217
• 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: 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): 05/04/2023

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: 02/17/2025
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 54 KG