MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC 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	11/13/2023
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.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 or Problem Description
It was reported that a 23mm 11060a aortic valved conduit was explanted and replaced with another 23mm 11060a avc after an implant duration of two (2) months, and twenty-four (24) days due to unknown reason.
Event or Problem Description
It was learned through implant patient registry and medical record that a 23mm 11060a aortic valved conduit in aortic position was explanted after an implant duration of two (2) months, twenty-three (23) days due to recurrent bioprosthetic endocarditis.The replacement is another 23mm 11060a konect avc.The patient was discharged on pod #16.Per medical record: the patient was discharged and completed 6 weeks of antibiotics from her index aortic valved conduit implant due to endocarditis.The patient presented two (2) months and 21 days later with right elbow pain for which there was concern for septic elbow, the cultures were negative, elbow pain presumed embolic.A tee revealed a new vegetation on the aortic valve and moderate mr.The indication for surgery recurrent endocarditis.The patient underwent redo sternotomy, aortic annular reconstruction with bovine pericardium, aortic root replacement using a 23mm 11060a aortic valve using a cabrol technique with reimplantation of the coronaries and mvr using a 27mm mitris valve, and pacemaker generator and lead removal.Vegetations on the aortic valve were sent for culture.There was phlegmon around the aortic root.The mitral valve was explanted and replaced due to concern for drop lesions on the leaflet.The aortic mitral curtain was intact.It is noted post implant heart function looked preserved; valves looked well seated without any significant leaks.The patient was transferred to cticu in critical but stable condition.A leadless pacemaker was implanted on pod #8.This is a 45-year-old female with a history of endocarditis s/p avr ( (b)(6) 2023), complete heart block s/p ppm.
Additional Manufacturer Narrative
H11: corrective data: this event was found to be a duplicate and was previously submitted under medwatch #40292.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.

• 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: 18291891
• Report Number: 2015691-2023-18212
• Device Sequence Number: 12429268
• Product Code: LWR
• UDI-Device Identifier: 00690103201383
• UDI-Public: (01)00690103201383(17)240531
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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 Model Number: 11060A
• Device Catalogue 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: 11/13/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Required Intervention; Life Threatening
• Patient Age: 45 YR
• Patient Sex: Female