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

Model Number	11060A
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the subject device is not available for evaluation, as device tracking returns are pending per investigation.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 learned through medical records of 2024-11882-01 that a patient with a 29mm 11060a valved conduit was explanted after an implant duration of 2 months due to aortic root pseudoaneurysm.The explanted device was replaced with a 29mm 11060a valve.Per medical records, the patient presented with pericardial effusion.Ct scan demonstrated a pseudoaneurysm at the level of the root.He stabilized medically and anticoagulation was withdrawn, and a repeat ct scan demonstrated enlargement of the pseudoaneurysm.The patient underwent redo sternotomy.Intraoperatively, preliminary evaluation showed aortic root dehiscence, especially in the region of the right-non commissure.Given the rigidity of the tissue surrounding it and the fibrosis due to the pseudoaneurysm/contained rupture, the surgeon decided to do a redo root replacement.The previously implanted valved conduit was explanted and was replaced with another 29mm 11060a konect resila aortic valved conduit.The areas of the distal anastomosis and the very distal ascending aorta were then excised, as was a small portion of the lesser curvature of the arch.A 28- mm dacron graft.The explanted device was sent to pathology and a specimen was sent to microbiology.Post bypass tee revealed relatively preserved left ventricular function with some moderate dysfunction of the right ventricle which improved progressively over time.The patient was taken to surgical intensive care in stable condition.The patient was discharged from the hospital on pod# 9.
Additional Manufacturer Narrative
H11: corrected data: 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 through medical records of (b)(4) that a patient with a 29mm 11060a valved conduit was explanted after an implant duration of 2 months due to aortic root pseudoaneurysm.The explanted device was replaced with a 29mm 11060a valve.Per medical records, the patient presented with pericardial effusion.Ct scan demonstrated a pseudoaneurysm at the level of the root.He stabilized medically and anticoagulation was withdrawn, and a repeat ct scan demonstrated enlargement of the pseudoaneurysm.The patient underwent redo sternotomy.Intraoperatively, preliminary evaluation showed aortic root dehiscence, especially in the region of the right-non commissure.Given the rigidity of the tissue surrounding it and the fibrosis due to the pseudoaneurysm/contained rupture, the surgeon decided to do a redo root replacement.The previously implanted valved conduit was explanted and was replaced with another 29mm 11060a konect resila aortic valved conduit.The areas of the distal anastomosis and the very distal ascending aorta were then excised, as was a small portion of the lesser curvature of the arch.A 28- mm dacron graft.The explanted device was sent to pathology and a specimen was sent to microbiology.Post bypass tee revealed relatively preserved left ventricular function with some moderate dysfunction of the right ventricle which improved progressively over time.The patient was taken to surgical intensive care in stable condition.The patient was discharged from the hospital on pod# 9.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.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irivne 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: 20232957
• Report Number: 2015691-2024-07157
• Device Sequence Number: 12989818
• Product Code: LWR
• UDI-Device Identifier: 00690103201406
• UDI-Public: (01)00690103201406(17)270123
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male