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

Model Number PVF-S

Device Problem Leak/Splash (1354)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/22/2022

Event Type  Injury  

Event 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.

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.

Manufacturer Narrative

Updated fields: b4, b5, g3, g6, h2, h6.

Event 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.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Type of Device: 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
• MDR Text Key: 300161127
• Report Number: 3005687633-2022-00139
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 08022057015365
• UDI-Public: (01)08022057015365(240)PVF-S(17)260221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011/S013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVF-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female