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

Model Number	11060A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through implant patient registry and medical records that a patient with a 27mm 11060a aortic valved conduit was explanted after an implant duration of 1 day due to unknown reason.The provided medical records did not mention the 27mm 11060a aortic valved conduit.Per medical records, the patient presented with right jaw pain, chest pain, and ble weakness.The patient was found to have ct evidence of a type a aortic dissection.Redo sternotomy was performed for the aortic dissection repair and aortic valve replacement with a 25mm konect valved conduit.Intra-operatively, once the aorta was unclamped, the patient experienced v-fib requiring internal defib x6.Intra-op tee noted a dilated lv with normal biventricular function.The 25mm konect valved conduit was implanted successfully without complication.The patient was taken to the icu post procedure.The patient was discharged pod #4.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional 'customer complaint'.The information reported may or may not be related to the edwards device.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: attempts to obtain additional information and for product return have been made.The healthcare provider has not returned the explanted valve or provided any additional information at this time.There is currently insufficient information to determine the root cause of this event.It is unknown if patient and/or procedure related factors may have caused or contributed to this event.There has been no allegation of a product malfunction.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.If new information becomes available, a supplemental report will be submitted.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Common Device Name: 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: jason reves ; 1 edwards way; irvine, CA 92614 ; 9502503859
• MDR Report Key: 25235535
• Report Number: 2015691-2026-15388
• Device Sequence Number: 10357409
• Product Code: LWR
• UDI-Device Identifier: 00690103201390
• UDI-Public: (01)00690103201390(17)280914
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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 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: 04/29/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 60 YR
• Patient Sex: Male