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

Model Number	PVS25
Medical Device Problem Codes	Positioning Failure (1158); Migration (4003)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
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.Since the device was not returned for analysis, the manufacturer couldn't perform further investigation on the explanted prosthesis.Based on the information received, no device anomalies or malfunction were noted or suspected both at the time of perceval implant and explant.As per medical judgment received, the insufficiency was due to a displacement of the perceval prosthesis in the left ventricle caused by excessive decalcification and consequent tissue damage to the patient's native annulus which prevented an adequate anchoring of the prosthesis.As such, the root cause of the reported event can be attributed to an unintended user error occurred at the time of perceval implant.
Event or Problem Description
The manufacturer was informed of a perceval pvs size l valve explant occurred on (b)(6) 2024 due to severe aortic insufficiency.The prosthesis had been implanted on (b)(6) 2024.As per medical judgement received, there was no anomaly or malfunction of the perceval prosthesis noted or suspected and the insufficiency occurred because the valve slipped into the left ventricle due to excessive decalcification performed on the patient's aortic annulus at the time of implant.Reportedly, the native annulus was very calcific, and an extreme decalcification needed to be performed which led to a damage of the annulus.This prevented an adequate anchoring of the perceval prosthesis despite the correct sizing performed.The reoperation was conducted with no complications to the patient and the perceval valve was ultimately replaced with a sutured bioprosthesis from a different manufacturer (edwards lifesciences magna ease size 25).The patient underwent standard medication and treatment after reintervention.The healthcare facility did not deem it necessary to perform any specific analysis on the explanted perceval prosthesis, and the manufacturer was informed that the device will not be returned for analysis.

• 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 V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 19534051
• Report Number: 3004478276-2024-00140
• Device Sequence Number: 6216374
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)260413
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/01/2024

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: 04/13/2026
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2022
• 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 Sex: Male