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

Model Number	11060A27
Medical Device Problem Codes	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)
Health Effect - Clinical Codes	Thrombocytopenia (4431); Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Thrombosis is a well-recognized complication of prosthetic devices.Device thrombosis is the formation of blood clots on the device/graft.There may be cases of incidental finding by imaging (ct scan) of thicken leaflets (halt) when the patient will benefit from a close follow-up and may be treated with oral anticoagulant.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is due to another device.
Event or Problem Description
It was reported through the patient support center, 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.On (b)(6) 2023 impella was removed complicated by bleeding.Tee showed 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.On (b)(6) 2024, 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.On pod #44, the patient was discharged home.
Additional 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 or Problem 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
• 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: 18511275
• Report Number: 2015691-2024-00412
• Device Sequence Number: 6985036
• Product Code: LWR
• UDI-Device Identifier: 00690103201390
• UDI-Public: (01)00690103201390(17)260808
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/27/2024

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: 08/08/2026
• Device Model Number: 11060A27
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 01/16/2024; 02/21/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 02/07/2024; 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• 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; Required Intervention; Other; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male