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

Model Number	PVS21
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer was informed that a patient who had a perceval valve size s implanted on (b)(6) 2021, now has generated svd.According to the original operative record, annulus diameter measured intraoperatively was 22 mm; implanted as usual, with a note that the rcc of the prosthetic valve appeared slightly folded.Postoperative tte showed no paravalvular leakage and trivial transvalvular leakage.Reportedly, patient was hospitalized for heart failure; marked ascites due to concomitant liver cirrhosis, but symptoms improved after paracentesis and was discharged.Ct revealed calcification of all three cusps; diagnosed as svd rather than prosthetic valve thrombosis.Patient's medications are reported as: furosemide 20 mg, bayaspirin 100 mg, takecab 10 mg, febuxostat 10 mg, bisoprolol fumarate 2.5 mg, loflazepate ethyl 1 mg, ursodeoxycholic acid 300 mg, amitiza capsule 12 g, dayvigo 2.5 mg, tolvaptan 11.25 mg, spironolactone 25 mg, liona tablet 500 mg, lixiana 15 mg.
Additional Manufacturer Narrative
Manufacturer is retrieving and reviewing the manufacturing documents.A follow up report will be provided upon completion of this activity.
Additional Manufacturer Narrative
Updated sections b4, g3, g6, h2, h6.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.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 (i.E, kidney disease) may have contributed to the structural valve deterioration observed in this perceval s valve, but since limited information is available, this cannot ultimately be confirmed.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: 24106756
• Report Number: 3004478276-2026-00110
• Device Sequence Number: 5878751
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)231106
• 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: 2021
• 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): 02/20/2026

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: 11/06/2023
• Device Model Number: PVS21
• Device Catalogue Number: PVS21
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 01/18/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2020
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 50 KG