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

Model Number	PVF-XL
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Still implanted.
Event or Problem Description
The manufacturer received information that a patient implanted with perceval plus valve size xl on (b)(6) 2023 was diagnosed with stenosis, worsening and high gradients.(pmean: 31 mmhg; ppeak 49mmhg) at a follow up visit performed in (b)(6).At the visit the patient presented shortness of breath.Reportedly, the device functionality was good after implant.High gradients were noted though since then (discharge: pmean 18mmhg; ppeak 32mmhg; 30 days visit: pmean 14mmhg; ppeak 34mmhg), still with the varc3 expectation indicating no failed implant.Reportedly, the patient underwent avr due to high-grade stenosis in absence of insufficiency.Patient presented the following risk factors: diabetes mellitus ii, hypercholesterolemia, obesity.No coagulation disorders were reported.Patient was under aspirin prior to implant and treatment with aspirin + marcumar was indicated for 3 weeks after implant.Patient's inr was 1.1 at discharge and 1.12 at the follow up visit performed in (b)(6).As per medical judgement received, by checking the pre-operative measurements, an oversizing of the perceval valve cannot be excluded.There is also a suspect for halt and thrombosis, since there is no warranty that patient was compliant to anticoagulation therapy after surgery.As reported, at the echo check, 2 leaflets of the perceval valve showed stiffness.A test on bacteria was done in (b)(6) and based on its results, infection was ruled out.Treatment with marcumar for 4 weeks has been prescribed to the patient and a follow up visit will be performed in (b)(6) 2023.According to medical judgement, no clear diagnosis can be posed until the next follow up visit.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval plus heart valve, model # pvf-xl, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacture¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model # pvf-xl) perceval plus heart valve at the time of manufacture and release.Since the prosthesis remains implanted, the manufacturer couldn't perform further investigation on the device.Based on the information and medical judgement received, there is the suspicion that the elevated gradients observed in this case could be due to hyperattenuated leaflet thickening (halt) , and thrombosis, since there was no warranty that patient was compliant to anticoagulation therapy after surgery.It is known from literature that halt is a phenomenon present in ¿10% to 20% of patients undergoing surgical aortic valve replacement and transcatheter aortic valve replacement, and it is related to a subclinical leaflet thrombosis.Halt can progress to reduced leaflet motion (rlm), but it is a dynamic phenomenon that can as well regress at variable intervals after valve implantation.In a recent study (cerillo et al., ann thorac surg.2018 jul;106(1):121-128) the authors identified subclinical thrombosis as the cause of increased transprosthetic gradients in a group of patients who had received perceval valves in which altered kinetics of the leaflets due to the valve oversizing was identified.As reported, prosthesis oversizing cannot be excluded in the present case and this factor could have contributed to the observed hypoattenuating leaflet thickening.As such, the root cause of the reported event can be reasonably attributed to valve oversizing combined with a poor compliance of the patient with the anticoagulant therapy.
Additional Manufacturer Narrative
The event description has been updated based on information received regarding the last follow up visit performed by the patient in (b)(6) 2023.The new information received doesn't change the investigation conclusion.
Event or Problem Description
The manufacturer received information that a patient implanted with perceval plus valve size xl on (b)(6) 2023 was diagnosed with stenosis, worsening and high gradients.(pmean: 31 mmhg; ppeak 49mmhg) at a follow up visit performed in september.At the visit the patient presented shortness of breath.Reportedly, the device functionality was good after implant.High gradients were noted though since then (discharge: pmean 18mmhg; ppeak 32mmhg; 30 days visit: pmean 14mmhg; ppeak 34mmhg), still with the varc3 expectation indicating no failed implant.Reportedly, the patient underwent avr due to high-grade stenosis in absence of insufficiency.Patient presented the following risk factors: diabetes mellitus ii, hypercholesterolemia, obesity.No coagulation disorders were reported.Patient was under aspirin prior to implant and treatment with aspirin + marcumar was indicated for 3 weeks after implant.Patient's inr was 1.1 at discharge and 1.12 at the follow up visit performed in september.As per medical judgement received, by checking the pre-operative measurements, an oversizing of the perceval valve cannot be excluded.There is also a suspect for halt and thrombosis, since there is no warranty that patient was compliant to anticoagulation therapy after surgery.As reported, at the echo check, 2 leaflets of the perceval valve showed stiffness.A test on bacteria was done in september and based on its results, infection was ruled out.Treatment with marcumar for 4 weeks has been prescribed to the patient and a follow up visit was performed on (b)(6) 2023.The patient still presented with symptoms (shortness of breath) at the follow up visit performed.As per information received, the prosthesis appearance was normal at the tee echo check, with no insufficiency detected but still elevated gradients which were attributed to prosthesis oversizing.There was a stenosis of the mitral valve observed and a dilated lv.Lv and rv systolic function was normal.As per medical judgement received, the symptoms could be also due to copd or severe obesity.A decision was made to continue the marcumar therapy and perform a tte in 6 months.

• Brand Name: PERCEVAL PLUS 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: 18109369
• Report Number: 3004478276-2023-00196
• Device Sequence Number: 15382987
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)260821
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011/S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 03/08/2024

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
• Device Expiration Date: 08/21/2026
• Device Model Number: PVF-XL
• Device Catalogue Number: PVF-XL
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 12/01/2023; 02/07/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 12/28/2023; 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2022
• 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: Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 139 KG