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

Model Number 11500A21

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

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

Event Date 02/19/2024

Event Type  Injury  

Event Description

It was reported that a patient with a 19mm 11500a inspiris valve was placed under evaluation for valve-in-valve intervention after an approximate implant duration of five (5) years due to unknown reasons.

Manufacturer Narrative

H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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.Structural valve deterioration (svd) is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Alternatively, non-structural valve dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.An engineering evaluation is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A capa/scar/pra is not required as there are no confirmed product or labeling non-conformances and no other triggers are met.The most likely cause is patient factors, including cad and hld.

Event Description

It was reported and learned through investigation that a patient with a 21mm 11500a inspiris valve in the aortic position was placed under evaluation for valve-in-valve intervention after an implant duration of four (4) years, two (2) years due to severe aortic stenosis.The patient has presented with doe, in heart failure with reduced ef.Per information received, the valve seems to be opening well in some views, ava 0.8cm2 to 1.0cm2 and mean pressure gradient 25mm-30mmhg.There was consideration between the valve being stuck versus ppm.

Manufacturer Narrative

B7: severe calcific aortic stenosis, s/p avr (12/2019), benign hypertensive heart disease, severe lv dysfunction, hfref, cad, s/p acute non st mi, paf, htn, hld.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18914876
• MDR Text Key: 337791900
• Report Number: 2015691-2024-02069
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194975
• UDI-Public: (01)00690103194975(17)210228
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2024

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 Expiration Date: 02/28/2021
• Device Model Number: 11500A21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 03/15/2024; 04/22/2024
• Supplement Dates FDA Received: 04/09/2024; 04/24/2024
• Date Device Manufactured: 03/01/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male