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

Model Number 11500AJ23

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Device Stenosis (4066)

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

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remains implanted.Attempts to retrieve additional information are in process.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 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 23mm 11500aj aortic pericardial valve has been placed under consideration for a valve-in-valve procedure after an implant duration of approximately four (4) years due to aortic stenosis and regurgitation.The patient presented with pressure gradient increase.

Manufacturer Narrative

Updated sections: a1, a2, a3, a4, b5, d4 serial number and expiration date, d6a, g3, g6, h4, h6 health effect - clinical code, device code(s), type of investigation, type of investigation, and investigation conclusions.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.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.Such failure modes may occur singularly or concomitantly.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

Event Description

It was reported that a patient with a 23mm 11500aj aortic pericardial valve has been placed under consideration for a valve-in-valve procedure after an implant duration of four (4) years and two (2) months due to aortic stenosis and regurgitation secondary to structural valve deterioration.The patient presented with pressure gradient increase, heart failure, and dyspnea.The device was not returned for evaluation as it remained implanted.

Manufacturer Narrative

Updated sections: b5, g3, g6, and h6 health effect - impact code.

Event Description

It was reported that a patient with a 23mm 11500aj aortic pericardial valve underwent a valve-in-valve procedure after an implant duration of four (4) years, five (5) months due to aortic stenosis and regurgitation secondary to structural valve deterioration.The patient presented with pressure gradient increase, heart failure, and dyspnea.The procedure was performed with a 26mm 9755rsl transcatheter valve.The device was not returned for evaluation as it remained implanted.

• 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 ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17232347
• MDR Text Key: 318178088
• Report Number: 2015691-2023-14272
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2020
• Device Model Number: 11500AJ23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 69 KG