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

Model Number	11060A
Medical Device Problem Codes	Microbial Contamination of Device (2303); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Endocarditis (1834); Insufficient Information (4580)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through implant patient registry that a 29mm 11060a aortic valve was explanted after an implant duration of four (4) months, fourteen (14) days due to unknown reasons.The avr procedure was completed with another 29mm 11060a aortic valve.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
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.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.
Additional Manufacturer Narrative
H11: corrective data: based on the additional information obtained, this event is no longer considered reportable, and this correction is being submitted.All pertinent information available to edwards lifesciences has been submitted.
Event or Problem Description
It was learned through implant patient registry and medical record that a 29mm 11060a aortic valved conduit was explanted after an implant duration of four (4) months, fourteen (14) days due to prosthetic valve endocarditis with pseudoaneurysm of the aortic root.The avr procedure was completed with another 29mm 11060a aortic valve.The patient was discharged to home in stable condition on pod# 11.Per medical record: the patient recently discharged from hospital on (b)(6) 2023 and was discharged on prolonged antibiotics due to sternal infection, bacteremia and positive mrsa/meningitis blood cultures.The patient presented one month and ten days post discharge with a pulsating mass in chest and was diagnosed with a significant pseudoaneurysm of aortic root and prosthetic valve endocarditis.A pre op tee showing large 10cm pseudoaneurysm coming from the lvot, and functional aortic valve.The patient was taken to surgery.Findings at surgery showed a large pseudoaneurysm around ascending aorta originating from lvot and significant dehiscence of the prior aortic graft.There was clear infection around the aortic root graft.The patient underwent reop of prior aortic root replacement and avr (bentall procedure), using a 29mm 11060a avc, a cabrol replacement of the left main using graft, patch repair of the innominate vein, pseudoaneurysm repair of lvot.A post op tee showed a well seated prosthetic valve with no pvl, no residual flow in pseudoaneurysm.Preserved lv and rv function.Pod #6 echo aortic valve well seated, gradient normal and prosthetic aortic root well seated.A ppm was implanted on pod#6 due to chb.On pod # 7 multiple teeth were extracted.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 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: 18461442
• Report Number: 2015691-2024-00130
• Device Sequence Number: 3167190
• Product Code: LWR
• UDI-Device Identifier: 00690103201406
• UDI-Public: (01)00690103201406(17)260405
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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: 04/05/2026
• Device Model Number: 11060A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 01/07/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male