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

Model Number	PVF-S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, a perceval plus sutureless aortic heart valve pvf-s was implanted.After the implantation of this perceval plus valve, there was residual ar.Based on the 2d echocardiography report, aortic root diameter, left ventricle ed and es dimension, ivs es, left ventricular pw(ed and es) was within the normal value range (3.1, 4.7 and 3.3, 1.5, 0.9 and 1.1, respectively).Left atrial dimension and ivs ed was little bit out of the ravage of normal value (4.2 and 1.3, respectively).2d imaging in plax, sax and apical views revealed concentric lvh & normal lv systolic function.Movement of the septum, anterior, inferior posterior and lateral walls are normal.Lvef is 55%.Mitral valve opening is normal.No evidence of mitral valve prolapse is seen.Mildly dilated la with no apparent la / laa clot seen.Avd; aortic valve thickened & calcified with severe calcific as (ava 0.41sqcm by continuity equation, sv 34ml, dvi 0.16, mpg 42mmhg, max pg 68mmhg, max velocity 412cm/sec) with mild ar, aortic annulus 20.5mm.Tricuspid valve leaflets move normally.Pulmonary valve is normal.Interatrial and interventricular septum are intact.No intracardiac mass or thrombus is seen.No pericardial pathology is observed.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.A follow up report will be provided upon receipt of the device or further information.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h6.
Event or Problem Description
On (b)(6) 2022, a perceval plus sutureless aortic heart valve pvf-s was implanted in a patient with severe calcified aortic stenosis.Based on the 2d echocardiography report, aortic root diameter, left ventricle ed and es dimension, ivs es, left ventricular pw(ed and es) was within the normal value range (3.1, 4.7 and 3.3, 1.5, 0.9 and 1.1, respectively).Left atrial dimension and ivs ed was little bit out of the ravage of normal value (4.2 and 1.3, respectively).2d imaging in plax, sax and apical views revealed concentric lvh & normal lv systolic function.Movement of the septum, anterior, inferior posterior and lateral walls are normal.Lvef is 55%.Mitral valve opening is normal.No evidence of mitral valve prolapse is seen.Mildly dilated la with no apparent la / laa clot seen.Avd; aortic valve thickened & calcified with severe calcific as (ava 0.41sqcm by continuity equation, sv 34ml, dvi 0.16, mpg 42mmhg, max pg 68mmhg, max velocity 412cm/sec) with mild ar, aortic annulus 20.5mm.Tricuspid valve leaflets move normally.Pulmonary valve is normal.Interatrial and interventricular septum are intact.No intracardiac mass or thrombus is seen.No pericardial pathology is observed.Based on the additional information received, while weaning off cpb, severe central ar with lv distension was noted.As such, the valve was explanted, a 19 mm mechanical valve was implanted, and patient was discharged in stable condition.As reported, the wound of the aorta was very horizontal.Based on the medical judgement received, the valve may got distorted because of the acute aortic angle between lv and aortic annulus.
Additional Manufacturer Narrative
Based on the information provided, there is a medical judgement that the event could be attributed to the patient's condition, i.E., "the valve may get distorted because of the acute aortic angle between lv and aortic annulus".Furthermore, there were no deficits noted during the production records review.As such, cause of the event was related to patient condition.
Additional Manufacturer Narrative
Based on the information provided, there is a medical judgement that the event could be attributed to the patient's condition, i.E., "the valve may get distorted because of the acute aortic angle between lv and aortic annulus".Furthermore, there were no deficits noted during the production records review.As such, cause of the event was related to patient condition.

• 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
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: roberta lamberti ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 15447364
• Report Number: 3005687633-2022-00139
• Device Sequence Number: 15334181
• Product Code: LWR
• UDI-Device Identifier: 08022057015365
• UDI-Public: (01)08022057015365(240)PVF-S(17)260221
• 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: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 04/10/2025

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: 02/21/2026
• Device Model Number: PVF-S
• Device Catalogue Number: PVF-S
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 09/19/2022; 04/10/2025; 04/10/2025
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 09/19/2022; 04/10/2025; 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2022
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female