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

Model Number 8300AB25

Device Problem Perivalvular Leak (1457)

Patient Problem Insufficient Information (4580)

Event Date 10/10/2022

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation as it remains implanted.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 Description

It was reported that this patient with an 8300ab 25mm intuity elite aortic valve, implanted for one (1) year and seven (7) months, underwent intervention due to pvl.It was learned the patient had severe pvl that needed to be repaired.The surgical team decided to insert and inflate a 26 true balloon to expand the stent and frame.The balloon was inflated 3 times to 4, 12, and 14 atms.The patient went from severe aortic insufficiency to trivial and a gradient of 20 to 12.Physicians were pleased with the final result.

Manufacturer Narrative

Added information to b5, e1, h6.

Event Description

It was reported that a patient with an 8300ab 25mm aortic valve, implanted for one (1) year and seven months, underwent intervention due to severe pvl.Per edwards internal review of tee imaging, there is pvl at the rcc, lcc and possibly a third pvl at the ncc (this area not well imaged).Total pvl grade is moderate.The surgical team decided to insert and inflate a 26 true balloon to expand the stent and frame.The balloon was inflated 3 times to 4, 12, and 14 atms.The patient went from severe aortic insufficiency to trivial and a gradient of 20 to 12.Physicians were pleased with the final result.

Manufacturer Narrative

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.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: 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: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15738851
• MDR Text Key: 303136021
• Report Number: 2015691-2022-09037
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103194500
• UDI-Public: (01)00690103194500(17)230915
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150036/S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2023
• Device Model Number: 8300AB25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/05/2022; 09/30/2023
• Supplement Dates FDA Received: 12/23/2022; 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Male