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

Model Number	PVS25
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with prior aortic stenosis sip surgical avr in 2017 at the (b)(6) va with a large perceval prosthesis· and tavr (evolute, unknown size) in (b)(6) 2019 at (b)(6) for prosthetic valve stenosis with a mild-moderate perivalvular leak, stable mild cardiomyopathy with normal lv dimensions.Biotronic dual chamber pacemaker for complete heart block after tavr, cad with very recent atherectomy/pci to mid lad, paf in nsr, iddm, cirrhosis, presbycusis, and other medical issues.Patient was evaluated initially for angina/dyspnea s/p lad atherectomy/pci last week and medical optimization which has been successful to resolve the symptoms.Patient's ef has been mildly depressed/stable since 2022 with no lv dilation, and no sign of infection of the valve complex.Patient is also newly anemic possibly from homolysis along with ams with unclear cause.There is no current indication for repeat valvular intervention, and surgery cannot be performed given the recent coronary intervention and the need for dapt.Reportedly, patient was evaluated a month ago by cardiology for chest pain, dyspnea, and dizziness.Tte showed ef 45-50%, lvidd 4.5/lvips 3.1, septal wall motion from pacing, mod-severe lvh~ mild rv systolic dysfunction, mild ms/mild to mod mr, prosthetic av mean gradient 21 mmhg with mild-mod pvl.An echo from bay pines in 2022 showed the same ef with no ai/as.Echo (b)(6) 2019 showed normal ef.Lhc (b)(6): severe heavily calcified mid lao and d1, mild circ and dominant rca.Av gradient 40 mmhg.Later cardiology made a correction (b)(6) 2025 °aorta (mmhg): 160/ so (incorrectly documented in lhc report, reviewed waveforms from cath lab and lv systolic (mmhg): 101.Edp (mmhg): 28 which would be consistent with no aortic valve stenosis.Patient underwent atherectomy/lithotripsy and pci to the mid lad with 3.0 x 28mm des (b)(6).In the following days patient reported ongoing chest pain.Ekgs paced and troponin 200s with flat trend.Patient had more angina, flash pulmonary edema, and htn episode.A repeat cath (b)(6) was patent, but lvedp 28mmhg.Another tte was stable.Patient was treated with diuresis and bp control with resolution of symptoms.Patient is going under tavr evaluation but there is no scheduled surgery yet.
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.Based on the manufacturer¿s clinical experience, considering that the device was being evaluated for tavr due to stenosis, it is possible that the root cause could be attributed to a structural valve deterioration of the device, which is a known inherent risk of the device.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 valve.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; buranby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 22536119
• Report Number: 3004478276-2025-00157
• Device Sequence Number: 20704927
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)190915
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2025

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: 09/15/2019
• 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: 06/17/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2016
• 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: 69 YR
• Patient Sex: Male