MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; REPLACEMENT HEART VALVE

Model Number 11000A23MM

Device Problems Fracture (1260); Incomplete Coaptation (2507)

Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

Model #: this model is not sold or marketed in the u.S.However, it is similar to device: model #11500a; brand name: edwards inspiris resilia aortic valve; pma #p150048.Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Svd, a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.The device was not returned for evaluation, as it remained implanted.Therefore, the root cause for the stenosis remains indeterminable.However, it is likely that patient related factors and the progression of the patient¿s underlying valvular disease pathology contributed to the event.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information through a clinical trial that a patient with a 23mm aortic valve, implanted in the pulmonic position, underwent a valve-in-valve procedure after an implant duration of 2 years, 10 months due to moderate pulmonary regurgitation and moderate pulmonary stenosis.The tpvr was performed with a 26mm successfully.The valve was post dilated with a 24mm true balloon at 15 atm resulting in fracture of the surgical valve ring.Post procedure echo demonstrated a stable valve prosthesis without significant pulmonary stenosis or pulmonary regurgitation.No perivalvular leak was identified.The patient was discharged home on pod #1 in stable condition.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8650710
• MDR Text Key: 146469475
• Report Number: 2015691-2019-01891
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2016
• Device Model Number: 11000A23MM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR
• Patient Weight: 29