MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC. INSPIRIS RESILIA; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11500A

Device Problems Perivalvular Leak (1457); Defective Device (2588)

Patient Problems Fatigue (1849); Aortic Valve Insufficiency/ Regurgitation (4450); Unspecified Respiratory Problem (4464)

Event Date 11/17/2020

Event Type  Injury  

Event Description

Edwards lifesciences inspiris resilia model 11500a aortic valve implanted on (b)(6) 2021 is discovered to be defective.I never fully recovered from the (b)(6) 2021 major surgery and reported difficulty breathing and fatigue at all subsequent check-ups.Cardiologist dr.(b)(6) who did the follow up check-up on (b)(6) 2021 heard valve leaking sounds; immediately confirmed it with a quick echo of the aortic valve and ordered a tee.The tee done by dr.(b)(6) on (b)(6) 2021 confirmed the aortic valve was defective; one of the 3 leaflets was ballooning outward which is causing aortic insufficiency.Valve does not have growth (vegetation), implant damage or thrombosis.Both the tee physician dr.(b)(6) and implant surgeon dr.(b)(6) confirm the valve is defective.It will have to be replaced soon as the valve is failing.It was supposed to be fixed with a tavr procedure scheduled for (b)(6) 2021 but my insurance company (b)(6) denied authorization on (b)(6) 2021, requiring open heart surgery instead of tavr to correct the valve.We are currently appealing that decision.Fda safety report id# (b)(4).

• Brand Name: INSPIRIS RESILIA
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC.
• MDR Report Key: 12975755
• MDR Text Key: 282104027
• Report Number: MW5105951
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: 150 MG RISEDRONATE ONCE PER MONTH; 81 MG BABY ASPIRIN DAILY; CALCIUM ; MIRALAX DAILY; VITAMIN D
• Patient Outcome(s): Required Intervention; Disability; Life Threatening
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White