MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	8300AB23A
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	08/02/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a 23mm 8300ab valve in the aortic position underwent a valve-in-valve procedure after an implant duration of 7 years 2 months due to leaflet calcification.The patient presented with syncope.The tavr was performed with a 23mm 9750tfx transcatheter valve.The patient was discharged on pod # 1.
Additional Manufacturer Narrative
The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.Svd is a logical and expected consequence of the chemical, mechanical, and immunological processes associated with bhv implantation.The common endpoint of all these factors is calcification and degradation.Svd is an acquired condition, intrinsic to bioprosthetic valves, characterized by deterioration of the leaflets or supporting structures, leading to thickening, calcification, tearing, or disruption of the prosthetic valve materials.These changes result in valvular dysfunction manifesting as stenosis and/or regurgitation with a consequent drop in hemodynamic efficacy of the valve.Despite the advancements in the heart valve industry, svd commonly begins 7- 8 years after implantation, with a considerably increased rate in patients with pertinent comorbidities and/or an implant duration of greater than 10 years.Prior investigations and extensive literature review have shown that svd is predominantly related to patient factors and implant duration rather than to manufacturing issues.Events related to device design, manufacturing, or use error tend to manifest at an earlier implant duration.Based on the information available, the most likely root cause is patient factors, including hyperlipidemia and coronary artery disease.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Common Device Name: 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: 20071224
• Report Number: 2015691-2024-06456
• Device Sequence Number: 11532019
• Product Code: LWR
• UDI-Device Identifier: 00690103194494
• UDI-Public: (01)00690103194494(17)210319
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 09/30/2024

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: 03/19/2021
• Device Model Number: 8300AB23A
• 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: 08/02/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2017
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male