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

Model Number	11060A23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through (b)(6) and medical records that a patient with a 23mm 11060a aortic valved conduit developed thrombus on pod #1.The patient expired on pod #5.Per medical records: the patient presented approximately two (2) years and five (5) month post tavr valve with an acute chf exacerbation and had severe recurrent aortic valve regurgitation, and aortic stenosis.A preoperative cath showed severe pulmonary htn with pressures 95/35mmhg and native mv stenosis.Prior to heart surgery the patient underwent id workup, dental extractions and renal failure requiring dialysis.The 21mm 3300tfx and non-edwards tavr valve were removed, and the patient underwent ascending and aortic root replacement with a 23mm 11060a aortic valved conduit with reimplantation of the coronaries and cabg x2.It is noted there was severe prosthetic leaflet degeneration/destruction, possibly suggestive of prior sub endocarditis.It is noted due to the long duration of cpb, the patient was left on central va ecmo with an open chest.On pod # 1 the patient returned to or in need of washout, the tee showed significant thrombus attached to the valve and obstructing the lvot and at risk of embolization.The thrombus was organized in appearance, and loosely attached to the ventricular side of the aortic valve.The thrombus was easily removed and sent for pathology.A post op tee confirmed the removal of the thrombus.The patient was transferred to cvicu on va ecmo.It was learned the patient expired on pod #5.
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.
Additional Manufacturer Narrative
The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Thrombosis is a well-recognized complication of prosthetic devices.Device thrombosis is the formation of blood clots forming on the device/graft.These clots could significantly impact the function of the valve resulting in harm.There may be cases of incidental finding by imaging (echocardiography and/or ct scan) of subclinical leaflet thrombosis (halt) where the patient will benefit from a close follow-up and may be treated with oral anticoagulant.The most likely cause is patient factors.

• Brand Name: EDWARDS KONECT RESILIA AORTIC VALVED CONDUIT
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine 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: 17394202
• Report Number: 2015691-2023-14838
• Device Sequence Number: 5955241
• Product Code: LWR
• UDI-Device Identifier: 00690103201383
• UDI-Public: (01)00690103201383(17)250830
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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 Expiration Date: 08/30/2025
• Device Model Number: 11060A23
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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; Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male