MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; TISSUE HEART VALVE

Model Number 8300ACD

Device Problems Calcified (1077); Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457); Difficult to Open or Close (2921); Patient Device Interaction Problem (4001)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

This device is not sold or marketed in the u.S.; however, it is similar to device model 8300ab, edwards intuity elite valve system (pma p150036).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.The subject device is not available for evaluation, as it remains implanted in the patient.The root cause of this event was most likely impacted by the progression of the patient's underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.

Event Description

It was reported that a patient with a 23 mm 8300acd aortic valve implanted for 7 years and 7 months underwent a valve-in-valve procedure due to calcification, mild to moderate paravalvular leak, severe stenosis, moderate regurgitation, fibrosis, and little to no movement of the leaflets.Patient presented with recurrent chf.The procedure was performed with a non-edwards 26mm aortic transcatheter valve.Patient tolerated the procedure well and was transported to the cvr unit postoperatively in stable condition.The patient was discharged home on pod #2.

Manufacturer Narrative

Updated sections: d4 expiration date, h4, h6 type of investigation.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.

• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12027186
• MDR Text Key: 258410130
• Report Number: 2015691-2021-03670
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2015
• Device Model Number: 8300ACD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 108