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

Model Number 8300AB23A

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 11/29/2021

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 that a patient with a 23mm 8300ab aortic valve was explanted after an implant duration of two years, 10 months due to moderate to severe pvl leak.The explanted valve was replaced with a 25mm konect.

Event Description

It was reported that a patient with a 23mm 8300ab aortic valve was explanted after an implant duration of two years, 10 months due to moderate to severe pvl leak, central intravalvular leak, and severe aortic insufficiency.The explanted valve was replaced with a 25mm konect.Per the medical records, the patient presented with acute on chronic systolic and diastolic class iii congestive heart failure.The patient underwent a redo avr and repair of aaa with a 28mm conduit graft.The valve was removed and replaced with a 25mm konect valve without complication.Postoperatively, the patient was transferred to the cvicu.Pod #1, the patient was in complete heart block requiring ppm placement.On pod #5, the patient was discharged home with home health in stable condition.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: d4 (expiration date), h4, and h6 (type of investigation, investigation findings, and investigation conclusions).The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.H11: corrective data: corrected section: h6 (component codes).Although the reported event was confirmed, the investigation could not conclusively determine the root cause.The root cause remains inconclusive.

• 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: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13079300
• MDR Text Key: 285544253
• Report Number: 2015691-2021-07019
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194494
• UDI-Public: (01)00690103194494(17)211030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

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
• Device Expiration Date: 10/30/2021
• Device Model Number: 8300AB23A
• Device Catalogue Number: 8300AB23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 01/05/2022; 02/02/2022
• Supplement Dates FDA Received: 01/28/2022; 02/02/2022
• Date Device Manufactured: 10/31/2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female