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

Model Number 11500AJ

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Insufficient Information (4580)

Event Date 03/16/2024

Event Type  Injury  

Event Description

Through implant patient registry it was learned 21mm 11500a aortic valve implanted two (2) years, three (3) months, was explanted due to unknown reasons.The explanted device was replaced with a 21mm 8300ab aortic valve.Patient post-operative status noted as in recovery.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional customer complaint.The information reported may or may not be related to the edwards device.

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded.Attempts to retrieve additional information is in process.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

Through implant patient registry and medical records, it was learned 21mm 11500a aortic valve implanted two (2) years, three (3) months, was explanted due to bioprosthetic aortic valve enterococcus faecalis endocarditis.The explanted device was replaced with a 21mm 8300ab aortic valve.Patient was transferred to cardiovascular intensive care unit.Per medical records, patient presented with shortness of breath and was unable to do normal activities.Patient reported a seven (7) week history of fevers associated with generalized weakness, diarrhea, and loss of appetite.Patient was evaluated and found to have clot/thrombus/endocarditis vegetations within the leaflets of the 21mm 11500a bioprosthetic valve.Patient was treated with iv antibiotics.Intraoperative tee demonstrated vegetations, which were quite fibrinous as well as mobile.It also showed the 21mm 11500a leaflets immobile.Upon inspection of the 21mm 11500a valve it was noted to be severely compromised by vegetation.The 21mm 11500a aortic valve was explanted and replaced with a 21mm 8300ab aortic valve.Patient was transferred to cardiovascular intensive care unit.

Manufacturer Narrative

Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• 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: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19115625
• MDR Text Key: 340271599
• Report Number: 2015691-2024-02869
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103198874
• UDI-Public: (01)00690103198874(17)210522
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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
• Device Operator: Health Professional
• Device Model Number: 11500AJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2019
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female