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

Model Number 11500A

Device Problems Insufficient Information (3190); Device Stenosis (4066)

Patient Problems Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 02/12/2024

Event Type  Injury  

Manufacturer Narrative

H10: additional narratives.Surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was not returned for evaluation, as it remains implanted.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

It was reported that a patient with a 21mm aortic valve is being evaluated for a valve-in-valve procedure after an implant duration of 4 years, 9 months due to unknown reasons.

Event Description

It was reported that a patient with a 11500a 21mm aortic valve is being evaluated for a valve-in-valve procedure after an implant duration of 4 years, 9 months due to stenosis.The patient presented with hf and sob.

Event Description

It was reported that a patient with a 11500a 21mm aortic valve underwent a valve-in-valve procedure after an implant duration of 4 years, 9 months due to stenosis.The patient presented with hf and sob.A 9755rsl 20mm was implanted.

Manufacturer Narrative

Updated b3, b5, and h6 per new information received.

Manufacturer Narrative

The most likely cause is patient factors, including chronic kidney disease (ckd) and diabetes mellitus (dm).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.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614
• MDR Report Key: 18769387
• MDR Text Key: 336127735
• Report Number: 2015691-2024-01282
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2020
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female