MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVF-L
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453); Transvalvular Pressure Gradient Increased (4854)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : tavi performed.
Event or Problem Description
The manufacturer was informed of a tavi procedure performed on a patient who was implanted with a perceval plus valve pvf-l on (b)(6) 2020.The diagnosis which led to the perceval implant was aortic valve stenosis.The diagnosis also included severe 3-vessels coronary disease and left ventricular dysfunction.A perceval valve size l was implanted through median sternotomy surgical approach.A concomitant procedure (4-vessels cabg) was performed before the valve replacement.The aortic native valve was tricuspid.The heart was found with increased dimension with fibrotic left ventricle.On (b)(6) 2024, a tavi procedure was performed with edwards sapien ultra size 26 valve, via right femoral artery, with good outcome.The pre-operative tee assessment reported mean gradient 40 mmhg, peak gradient 67 mmhg and ef 53%, tricuspid regurgitation grade ii type i, mitral regurgitation grade iii, left and right ventricular dysfunction.The patient medical history includes aht, dyslipidemia, diabetes t2, tumorectomy of the pancreas in 2019, and paroxysmal atrial fibrillation since jul 2020.The patient daily medications include apixaban 5mg, atorvastatin 20mg, propranolol chlorhydrate 40mg, flecainide acetate 100mg, furosemide 40mg.
Event or Problem Description
The manufacturer was informed of a tavi procedure performed on (b)(6) 2024 on a patient who was implanted with a perceval valve in (b)(6) 2020.The diagnosis which had led to the perceval valve implant was aortic valve stenosis.The diagnosis also included severe 3-vessels coronary artery disease and left ventricular dysfunction (ef 35%).The heart was found with increased dimension and fibrotic left ventricle.A perceval valve size l was implanted through median sternotomy surgical approach.A concomitant procedure ( 4-vessels cabg) was performed before the valve replacement.The aortic native valve was tricuspid.The patient was stable during the procedure and during the trasfer to the icu.Reportedly, the valve in valve procedure was indicated because of stenotic degeneretaion of the perceval bioprosthesis.Patient was experiencing dyspnea upfront mild effort, worsening since few months.The pre-operative assessment of the perceval valve showed: mean gradient 40 mmhg, peak gradient 67 mmhg, vmax 4.1 m/s, functional surface 0.83 cm2, absence of significant regurgitation.No data are available to the manufacturer regarding the functionality of the perecval prosthesis over time.The echo pre-operative assessment also reported tricuspid regurgitation grade ii type i, mitral regurgitation grade iii, left and right ventricular dysfunction with ef 53%.The ecg showed sinus rhythm with right bundle branch block - qrs 166ms.The transcatheter valve implanted was a sapien ultra (edwards lifesciences) size 26 and the implant was performed via right femoral artery.The procedure was successfully completed with no complications and a good result, with minimum residual insufficiency reported.The patient medical history includes aht,dyslipidemia, diabetes t2, tumorectomy of the pancreas in 2019, and paroxismal atrial fibrillation since (b)(6) 2020.The patient daily medications include apixaban 5mg, atorvastatin 20mg, propranolol chlorhydrate 40mg, flecainide acetate 100mg, furosemide 40mg.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval sutureless aortic bioprosthesis pvf-l sn (b)(6), 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.Since the device is not accessible for testing, the manufacturer couldn't perform further investigation on the prosthesis involved.Despite limited investigation could be performed on the involved device, it should be considered that, 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.Based on the information retrieved regarding the clinical history, the patient involved in the reported event presented multiple risk factors for structural valve deterioration (i.E.Dyslipidemia, hypertension, diabetes mellitus type ii).As such, the cause of the event can be reasonably traced to patient's condition.Ultimately, it should be considered that structural valve deterioration is listed as a possible adverse event in the perceval plus ifu.The event is, therefore, a known inherent risk of the device.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 18839191
• Report Number: 3005687633-2024-00102
• Device Sequence Number: 7215008
• Product Code: LWR
• UDI-Device Identifier: 08022057015389
• UDI-Public: (01)08022057015389(240)PVF-L(17)220225
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P150011/S013
• 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): 05/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2022
• Device Model Number: PVF-L
• Device Catalogue Number: PVF-L
• 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: 02/05/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 94 KG