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

Model Number	PVS23
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is following up with the site to retrieve additional information on the event, the device involved a patient's clinical history and risk factors.A follow up report will be provided upon receipt of further information and/or at the completion of the investigation.H3 other text : not explanted, viv performed.
Event or Problem Description
The manufacturer was informed that an indication for a valve in valve (viv) procedure was placed on an 84-year-old patient who had been implanted with a pvs 23mm perceval bioprosthesis on (b)(6) 2020.Reportedly, patient's native valve was tricuspid and perceval valve had been implanted because the native valve was calcified especially on the non-coronary leaflet.Patient had a history of ischemic cardiomyopathy.The surgery was performed without reported complications through median sternotomy and cabg (3 vessels) was executed as concomitant surgery.As reported, at the tte performed prior to the viv procedure, the perceval valve showed a vmax of 4.4m/s and a mean gradient of 47mmhg.As per additional information received, the viv procedure was performed in the week of (b)(6) using a sapien size 23 valve (edwards lifesciences) with a good outcome.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve, model # icv1209, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a model # icv1209 perceval heart valve at the time of manufacture and release.Since the device remains implanted in the patient, the manufacturer couldn't perform further investigation on the device involved in this event.Despite several attempts to follow up on the reported event, limited information has been made available to the manufacturer.As reported in the scientific literature, structural dysfunction is the major cause of failure of bioprosthetic heart valves and the principal underlying pathologic process is cuspal calcification.It is possible that the patient¿s clinical history and risk factors may have contributed to the structural valve deterioration observed in this perceval s valve.However, little clinical history was provided so this cannot ultimately be confirmed.In particular, it is not known if the patient presented further risk factors in addition to the reported ischemic cardiomiopathy.It is though known from literature that svd shares some risk factors with atherosclerosis and calcific aortic stenosis which were both present as patient conditions at the time of perceval implant.As a further note, since no diagnostic images were shared with the manufacturer, it was not possible to assess if the perceval valve position was adequate to guarantee a norrmal functioning or if mechanical load and stress distribution on the prosthesis could have contributed to the early degeneration observed in this case.Ultimately, it should be noted that structural valve deterioration is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.

• 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: 17874858
• Report Number: 3004478276-2023-00182
• Device Sequence Number: 19930129
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)220722
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/14/2023

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: 07/22/2022
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2018
• 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: 84 YR
• Patient Sex: Female