MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; TISSUE HEART VALVE

Model Number 11500A

Device Problems Calcified (1077); Gradient Increase (1270); Difficult to Open or Close (2921); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Syncope/Fainting (4411); Insufficient Information (4580)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information are in process.Based on the information received the cause of the event cannot be determined.If additional information is received a supplemental mdr will be submitted.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

Edwards received notification that a valve was explanted from the pulmonary position after an implant duration of approximately 3 years.

Event Description

Edwards received notification that a valve was explanted from the aortic position after an implant duration of approximately three (3) years and a six months due to calcification leading to stenosis and restricted motion of the leaflets.As reported, the valve also presented with a mild degree of pannus formation.As reported, the patient was symptomatic for aortic stenosis and at times almost presyncopal.A non-edwards valve was successfully implanted in replacement.The patient was noted as to be doing well.As reported, the patient had episodes of trigeminal rhythm one month later of the reoperation and was planned to underwent intervention to have a ppm implanted.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections a1, a2, b5, and h6.Calcification is a well-recognized failure mode of bioprosthetic valves.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), and mechanical stress related to the valve's hemodynamic performance.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Although patient factors are believed to play a crucial role in the development in bioprosthetic tissue calcification, the underline mechanism is still not fully understood.

Manufacturer Narrative

H3: device evaluation: customer reports of calcification, stenosis, pannus, and restricted leaflet motion were confirmed.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.X-ray also demonstrated moderate calcification on leaflet 1 and heavy calcification on leaflets 2 and 3.Extrinsic calcific deposits were observed on the surfaces of all three leaflets on the outflow aspect and on leaflets 2 and 3 on the inflow aspect.Moderate to heavy host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 8mm on leaflet 1 at the inflow aspect.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 3mm on leaflet 1 at the outflow aspect.Host tissue overgrowth on the stent circumference was moderate at both the inflow and outflow aspects.Calcification and host tissue overgrowth restricted leaflet mobility and led to stenosis.Additional narrative: updated sections d10, h6 (type of investigation, conclusions).

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11309247
• MDR Text Key: 231310278
• Report Number: 2015691-2021-01208
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2021

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: No Information
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 04/13/2021; 06/29/2021
• Supplement Dates FDA Received: 04/15/2021; 07/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 13 YR