MAUDE Adverse Event Report: EDWARDS LIFESCIENCES KONECT RESILIA AORTIC VALVED CONDUIT AVC; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	11060A
Medical Device Problem Codes	Calcified (1077); Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Chest Pain (1776); Heart Failure/Congestive Heart Failure (4446)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to edwards 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.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 or Problem Description
It was reported a patient with a 25mm 11060a aortic valved conduit implanted two (2) years, six (6) months, underwent valve-in-valve procedure due to severe bioprosthetic aortic valve stenosis and motion restricted leaflets.Tavr was successfully performed with a 26mm 9755rsl transcatheter valve.Patient was transferred to icu.Per medical records, patient presented with chest pain.Tee demonstrated severe aortic stenosis and severe leaflet restriction with only minimal mobility in the anterior most leaflet visualized.Iabp supported tavr was successfully performed with a 26mm 9755rsl transcatheter valve.Patient was transferred to icu.
Event or Problem Description
It was reported that a patient with a 25mm 11060a aortic valved conduit implanted two (2) years, six (6) months, underwent valve-in-valve procedure due to severe calcific aortic valve stenosis.Tavr was successfully performed with a 26mm 9755rsl transcatheter valve.Patient was transferred to icu.Per medical records, patient presented with chest pain, shortness of breath, and difficulty breathing.Tee demonstrated severely diminished left ventricular function with ejection fraction at 22%, severe aortic stenosis, leaflet calcification, with severe leaflet restriction with only minimal mobility in the anterior most leaflet visualized.Iabp supported tavr which was successfully performed with a 26mm 9755rsl transcatheter valve.Hemodynamics after valve deployment were within normal limits.Patient was transferred to icu post procedure.
Additional Manufacturer Narrative
Corrected b5, b7, h6.
Additional Manufacturer Narrative
Added information to d4, h4, h6.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.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 history of cibuspid aortic valve, end stage renal disease on dialysis and chronic coronary artery disease.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• 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: 19332401
• Report Number: 2015691-2024-03628
• Device Sequence Number: 14196135
• Product Code: LWR
• UDI-Device Identifier: 00690103193855
• UDI-Public: (01)00690103193855(17)230128
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 06/24/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 11060A
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 05/20/2024; 06/20/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/14/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2021
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 77 KG