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

Model Number 11500A

Device Problems Calcified (1077); Gradient Increase (1270); Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Fatigue (1849); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 08/31/2023

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 23mm aortic valve is being evaluated for a valve-in-valve procedure after an implant duration of 3 years, 9 months due to stenosis.

Manufacturer Narrative

The most likely cause is patient factors, including hyperlipidemia.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

It was reported that a patient with a 11500a 23mm aortic valve underwent a valve-in-valve procedure after an implant duration of 3 years, 9 months due to patient-prosthesis mismatch and moderate leaflet calcification.The patient presented with worsening doe, fatigue, and nyha iii.A 29mm non-ew transcatheter valve was implanted.Per medical records a the patient presented with nyha class iii hf symptoms.Tee demonstrated a well-seated aortic valve with leaflet excursion well preserved, however, valve dimensions were smaller compared to size of aorta.Moderate av calcification on ct was also noted.The patient underwent tavr procedure.Post deployment echo revealed excellent result.The patient was discharged on pod#.

Event Description

It was reported that a patient with a 11500a 23mm aortic valve underwent a valve-in-valve procedure after an implant duration of 3 years, 9 months due to patient-prosthesis mismatch and moderate leaflet calcification.The patient presented with worsening doe, fatigue, and nyha iii.A 29mm non-ew transcatheter valve was implanted.Per medical records a the patient presented with nyha class iii hf symptoms.Tee demonstrated a well-seated aortic valve with leaflet excursion well preserved, however, valve dimensions were smaller compared to size of aorta.Moderate av calcification on ct was also noted.The patient underwent tavr procedure.Post deployment echo revealed excellent result.The patient was discharged.

Manufacturer Narrative

The most likely cause is patient factors, including hyperlipidemia.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

It was reported that a patient with a 11500a 23mm aortic valve underwent a valve-in-valve procedure after an implant duration of 3 years, 9 months due to patient-prosthesis mismatch and moderate leaflet calcification.The patient presented with worsening doe, fatigue, and nyha iii.A 29mm non-ew transcatheter valve was implanted.Per medical records a the patient presented with nyha class iii hf symptoms.Tee demonstrated a well-seated aortic valve with leaflet excursion well preserved, however, valve dimensions were smaller compared to size of aorta.Moderate av calcification on ct was also noted.The patient underwent tavr procedure.Post deployment echo revealed excellent result.The patient was discharged.

Manufacturer Narrative

H10: additional narratives: updated b5, b7, d4, h4, and h6 per new information received.The most likely cause is patient factors, including hyperlipidemia.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 ; 9492506615
• MDR Report Key: 17811653
• MDR Text Key: 324181754
• Report Number: 2015691-2023-16149
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)210424
• 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: 11/17/2023

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: Health Professional
• Device Expiration Date: 04/24/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 10/30/2023; 10/30/2023; 10/30/2023
• Supplement Dates FDA Received: 11/16/2023; 11/16/2023; 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2019
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male