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

Model Number	11500A25
Medical Device Problem Codes	Calcified (1077); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	10/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient with a 25mm 11500a aortic valve implanted four (4) years, one (1) month, is being evaluated for valve-in-valve procedure due to severe aortic insufficiency.
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation as it remains implanted.Attempts to retrieve additional information is 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.
Additional Manufacturer Narrative
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.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.
Additional Manufacturer Narrative
Added information to b5, h6.
Event or Problem Description
It was reported a patient with a 25mm 11500a aortic valve implanted four (4) years, one (1) month, underwent valve-in-valve procedure due to severe aortic insufficiency.Tavr was successfully performed with a 26mm 9755rsl transcatheter valve.
Event or Problem Description
It was reported a patient with a 25mm 11500a aortic valve implanted four (4) years, one (1) month, underwent valve-in-valve procedure due to severe aortic insufficiency and moderate calcification.Patient presented with congestive heart failure.Tavr was successfully performed with a 26mm 9755rsl transcatheter valve.Patient tolerated the procedure well and was transferred to ccu in stable condition.Patient was discharged home on pod # 1.
Additional Manufacturer Narrative
Added information to b5, b6, b7, h6.
Additional Manufacturer Narrative
Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valves hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards tissue valves due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Calcification is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.The most likely cause is patient factors, including a history of dyslipidemia and non-obstructive cad.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Common Device Name: 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: 18167298
• Report Number: 2015691-2023-17603
• Device Sequence Number: 14877286
• Product Code: LWR
• UDI-Device Identifier: 00690103201383
• UDI-Public: (01)00690103201383(17)210408
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2021
• Device Model Number: 11500A25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/21/2023; 12/20/2023; 02/09/2024; 02/13/2024
• Initial Report FDA Received Date: 11/19/2023
• Supplement Report FDA Received Date: 12/15/2023; 12/29/2023; 02/09/2024; 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male