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

Model Number	8300AB25A
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through medical records (b)(6) that a 25mm 8300ab valve implanted in the aortic position had pvl.Per medical records, the patient initially underwent redo avr as a result of endocarditis (b)(6) with perivalvular abscesses, partially dehisced with slight rocking motion, severe paravalvular regurgitation.It was decided to implant a 25mm 8300ab valve, expanding it to help fill the abscess cavities.The subannular abscess cavity had very poor integrity, and it was still possible to distract the tissues around the deployed valve.It was determined that there was no other option and the aortotomy was then closed.Post bypass tee demonstrated significant paravalvular leak, as expected following inspection of the deployed 25mm 8300ab valve.However, there was simply no other way to provide the patient with an aortic valve, so no further interventions were performed.The abscess/infection was subannular and had unfortunately destroyed the tissues to the point that further attempts at repair would undoubtedly be unsuccessful.The patient was taken into the icu in critical condition.The patient was transitioned to comfort care measures only and the patient expired on pod#1.The patient is a 69 y.O.Male with history of htn, congenital bicuspid aortic valve s/p avr, cad s/p cabgx1 svg to rca, paroxysmal a-fib s/p left atrial appendage ligation currently on warfarin, pacemaker implanted.
Additional Manufacturer Narrative
H11: 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
H11.Additional narrative: updated d4, h4, and h6.The most likely root cause is patient-related factors, including, congenital bicuspid aortic valve (bav), coronary artery disease (cad), history of coronary artery bypass graft (cabg).The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• 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: 20642852
• Report Number: 2015691-2024-08465
• Device Sequence Number: 7507062
• Product Code: LWR
• UDI-Device Identifier: 00690103194500
• UDI-Public: (01)00690103194500(17)261010
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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: 8300AB25A
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2022
• 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: Other; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male