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

Model Number PVS25

Device Problem Calcified (1077)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Pleural Effusion (2010); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/14/2021

Event Type  Injury  

Event Description

On (b)(6) 2016, the patient with severe aortic stenosis (bicuspid native valve) received a perceval s size l.An aortocoronary bypass was also performed.The patient was discharged from the hospital on (b)(6) 2016 in good conditions and asymptomatic.The echo taken prior to discharge showed a normo-functioning prosthesis (mean/peak gradients of 16/32mmhg and no leaks).The manufacturer was informed that the patient was hospitalized on (b)(6) 2021 due to dyspnea, with heart failure and bilateral pleural effusion.The echo showed the prosthesis with calcified and hypomobile cusps, and with severe stenosis (mean/max gradient 68/109mmhg), mild intraprosthetic insufficiency.The data are compatible with severe prosthetic dysfunction (fibrocalcific degeneration with stenosis).On (b)(6) 2021, the perceval valve was explanted and replaced with a carpentier-edwards bioprosthesis intuity 23 mm.The patient underwent a definitive pacemaker implantation on (b)(6) 2021 due to complete atrio-ventricular block and was discharged to cardiological rehabilitation on (b)(6) 2021.As reported in the operational document received, the perceval l was implanted as of necessity since the annulus would have accommodated maximum a bioprosthesis size 21.The patient's bicuspid valve was characterized by partial fusion of the right and left coronary cusps.

Manufacturer Narrative

The gross examination performed on the returned prosthesis confirmed that the valve appeared geometrically deformed.The visual inspection according to the manufacturing specifications cannot be completed due to the deeply altered state of the returned prosthesis.The prosthesis underwent histopathological examination.The stent and the skirt were covered by fibrous pannus that on the inflow side protruded 3-6mm into the lumen, narrowing the annulus, and contributes to stenosis.The tops of all posts were covered by fibrous pannus that grew on the free edges of leaflets and also so contributes to stenosis.Fibrous pannus depositions were also visible on the crown, on all sinusoidal struts.Small calcified thrombus depositions were visible on some inflow surfaces.Reddish areas due to coagulated blood entrapment were present on almost all surfaces.The free edge one leaflet was slightly outflow bent due to fibrous pannus and so caused a low degree of insufficiency.All the leaflets were stiff due to intrinsic and vegetating calcifications, detected at the x-rays examination and histological analyses.Hematoxylin and eosin stain showed that the collagen bundles were disrupted, defibrated and homogenated.Bacteria were not detected with the gram stain.The manufacturing and material records for the perceval heart valve, model #icv1210 , s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1210) perceval heart valve at the time of manufacture and release.This perceval s valve was explanted after 4 years and 2 months due to a reported prosthetic stenosis and mild intra-prosthetic insufficiency.Leaflets calcification, detected with visual, x-ray and histological analyses, caused stiffening and led to progressive valve stenosis.Pannus tissue overgrowth into the inflow lumen also contributed to valve stenosis.Aortic insufficiency likely resulted from inadequate leaflet coaptation caused by calcification of the leaflets.There was no evidence of endocarditis in the returned valve.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.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 conditions and risk factors (diabetes mellitus type ii, hypercholesterolemia, hypertension, obesity, dyslipidemia, smoker, mild-moderate copd, valvular and ischemic heart disease) may have contributed to the structural valve deterioration observed in this perceval s valve.In addition, based on the information available, the perceval l was implanted ''of necessity for annulus that would have allowed maximum a bioprosthesis size 21''.The perceval model pvs25 is indicated for aortic annulus diameters ranging between 23mm and 25mm according to the product instructions for use (ifu).Despite the patient¿s pre-operative annulus dimensions is not available, it is possible that the perceval valve pvs25 was initially oversized.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
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 11402623
• MDR Text Key: 234408117
• Report Number: 3004478276-2021-00131
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)200514
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

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 Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 88