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

Model Number 11060A

Device Problems Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Chest Pain (1776); Dizziness (2194); Insufficient Information (4580)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

The subject device is not available for evaluation, as it remains implanted in the patient.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.

Event Description

It was reported that a patient with a 27mm 11060a aortic valve underwent a valve-in-valve procedure after an implant duration of 9 months and 11 days due to stenosis and regurgitation.The procedure was performed with a 23mm 9755rsl transcatheter valve.

Manufacturer Narrative

Manufacturer narrative: updated sections; b5, b7, g3, g6, h6 health effect - clinical code, device code(s), and type of investigation.H11 corrected data: d1, d2, d4 model number and serial number, d6a, and g4 pma/510(k) number.

Event Description

It was reported that a patient with a 23mm magna aortic valve underwent a valve-in-valve procedure after and implant duration of 9 years and 8 months due to severe symptomatic stenosis.The patient presented with chest tightness and dizziness.The tavr procedure was successfully performed with a 23mm 9755rsl valve.The patient was in recovery post-procedure and discharged on pod #4.

Manufacturer Narrative

Updated sections: b7, g3, g6, h6 investigation findings, and investigation conclusions.The device history record (dhr) was unable to be performed, as the device lot/serial number was not provided.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 explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.Through further investigation, it was determined that the root cause of this event was most likely due to patient related factors.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18387520
• MDR Text Key: 331295046
• Report Number: 2015691-2023-18748
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11060A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Female