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

Model Number	PVS21
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve, 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 perceval heart valve at the time of manufacture and release.Device remains implanted.
Event or Problem Description
The manufacturer received following information through patient tracking department.Based on the information received, patient who was implanted a perceval sutureless aortic heart valve pvs21 on (b)(6) 2019, is undergoing tavr evaluation due to aortic stenosis.No further information is provided from the site at this time.
Additional Manufacturer Narrative
Manufacturer attempted to follow up with the event, but no further information was provided from the site despite the multiple attempts.Since limited information is available, the definitive root cause of the reported event cannot be established.However, from the document review performed, no manufacturing deficiencies were noted.As reported in the scientific literature, structural valve deterioration is the major cause of failure of bioprosthetic heart valves and the principal underlying pathologic process is cuspal calcification.Calcification can also cause stenosis due to cuspal stiffening.Calcific deposits are usually localized to cuspal tissue (intrinsic 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 and a definitive root cause cannot be stated at this time.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
• 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: 16422488
• Report Number: 3004478276-2023-00116
• Device Sequence Number: 5340629
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)220609
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/27/2023

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: 06/09/2022
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• 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: 01/26/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2019
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Female