MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11000A29MM

Device Problem Gradient Increase (1270)

Patient Problems Aneurysm (1708); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/10/2022

Event Type  Injury  

Manufacturer Narrative

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 Description

It was reported from the commence trial that a patient with a 29mm 11000a pericardial aortic valve aortic underwent explant after implant duration of 6 years, 5 months due to aortic valve stenosis, halt, and decreased mobility of the left cusp.The patient presented with chf, class 11 nyha symptoms.The explanted 29mm 11000a aortic valve was replaced with a 29mm 3300tfx pericardial valve.The patient was discharged home on pod #8.Per medical source documents the patient presented for ascending aortic root, ascending aortic arch aneurysm as well as redo avr.Halt was listed as an indication for surgery, findings at surgery indicated decreased mobility of the left cusp.The post op diagnosis in the op note indicated severe halt.The patient underwent redo avr with a 29mm pericardial magna valve, transverse aortic arch repair with a 30mm graft and ascending aortic aneurysm repair with a 30mm dacron graft.The post op tee showed lvef 60%.The patient tested positive for covid-19 in hospital and was asymptomatic.The patient was discharged on coumadin.

Manufacturer Narrative

Manufacturer narrative: updated sections: d4 expiration date, g3, g6, h4, h6 component code, type of investigation, investigation findings, and investigation conclusions.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.On occasion the device may be explanted with no evidence of malfunction and is otherwise performing as intended.Such as for aortic graft replacement, to enlarge aortic root, repair fistula, control bleeding/coagulopathy or other non-device related reason.In these events, the device may require removal to control bleeding or to facilitate repair of the injury.The event is not related to the device.Through further investigation, it was determined that the root cause of this event was most likely due to procedural factors.H11 corrected data: sections: b5, b7, d6b.And h6 health effect - clinical code.Based on the additional information, this event is no longer considered reportable.

Event Description

It was reported from the commence trial that a patient with a 29mm 11000a pericardial aortic valve aortic underwent explant after implant duration of 6 years, 5 months prophylactically during a procedure to repair ascending aortic, and aortic arch aneurysm.The explanted valve was replaced with a 29mm 3300tfx pericardial valve.The patient was discharged home on pod #8.Per medical records, the patient is a know case of ascending aortic, and aortic arch aneurysm.The patient presented with acute on chronic heart failure secondary to the enlarged aneurysm.The patient underwent aortic arch and ascending aortic aneurysm repair using a 30mm graft conduit.Due to the age of the bioprosthetic valve and the previous history of halt, the surgeon decided to redo the avr using redo avr.A 29mm 3300tfx pericardial valve was implanted in replacement.Post op tee showed well-seated and normally functioning replacement valve.The patient tested positive for covid-19 in hospital and was asymptomatic.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: 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: 16439075
• MDR Text Key: 310191940
• Report Number: 2015691-2023-11082
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/29/2016
• Device Model Number: 11000A29MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2023
• Date Device Manufactured: 02/26/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male