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

Model Number	11060A27
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Endocarditis (1834); Insufficient Information (4580)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Event or Problem Description
It was learned from the implant patient registry that a model 11060a 27mm aortic valved conduit was explanted and replaced with a 11060a 27mm aortic valved conduit after an implant duration of 7 months due to unknown reasons.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
Based on the additional information obtained, this event is no longer considered reportable, and this correction is being submitted.
Event or Problem Description
It was learned from the implant patient registry and medical records that a model 27mm 11060a aortic valved conduit was explanted and replaced with a 11060a 27mm aortic valved conduit after an implant duration of 7 months due to enterococcus faecalis bioprosthetic endocarditis and vegetation.Per medical records, patient presented to hospital with infective nephritis.Blood cultures returned positive for gram-positive cocci in pairs and found to be enterococcus faecalis.Patient was started on iv antibiotics.Infective endocarditis with septic emboli and inflammatory changes on ct scan in the mediastinum surrounding the proximal thoracic aorta.The 27mm 11060a valved conduit was explanted and noted to have large vegetation on it.Patient underwent re-do bentall.The explanted valved conduit was replaced with another 27mm 11060a valved conduit.The patient was transported to the icu in critically ill but stable condition.Patient was discharged to long term acute care facility on pod# 10.Pathology report, prosthetic valve leaflets with adherent fibrin and neutrophils; compatible with clinical history of endocarditis.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17712894
• Report Number: 2015691-2023-15793
• Device Sequence Number: 16691600
• Product Code: LWR
• UDI-Device Identifier: 00690103201390
• UDI-Public: (01)00690103201390(17)251106
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/04/2023

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: 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: 08/15/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/04/2023
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male