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

Model Number 11060A27

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Thrombocytopenia (4431); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

H10: 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 Description

It was reported that a 27mm 11060a after an implant duration of 2 - 3 weeks has the noncoronary leaflet which is not functioning properly and is fixing in a partially open position creating stenosis and regurgitation.The patient is scheduled to undergo a valve-in-valve procedure on (b)(6) 2024.

Manufacturer Narrative

H10: 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 Description

It was reported that a 27mm 11060a underwent a valve-in-valve procedure after an implant duration of 28 days due to leaflet not functioning properly, stenosis, insufficiency, and thrombus caused by non-edwards device with hit.The tavr was performed with an 26mm 9755rsl transcatheter valve.Patient initially underwent aortic root replacement with 27mm konect with impella placement on (b)(6) 2023.Echo showed noncoronary leaflet is not functioning properly and surgeon suspected it was because of the impella device.The patient developed hit and was placed on argotroban.The impella was removed complicated by bleeding.Medical records showed on tee both narrowing and insufficiency of the bioprosthetic valve related to partial thrombosis in the setting of hit, with at least two of the three leaflets with restricted motion positioned adjacent to the native rcc and lcc.The patient was deemed a poor surgical candidate; therefore, a valve-in-valve was performed with a 26mm s3ur.Tee post implant of transcatheter valve showed good valve positioning and no perivalvular leak.The patient left the cticu in stable condition.

• Brand Name: EDWARDS KONECT RESILIA AORTIC VALVED CONDUIT
• Type of Device: 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: 18511275
• MDR Text Key: 332891881
• Report Number: 2015691-2024-00412
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11060A27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• 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): Life Threatening; Required Intervention; Other; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male