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

Model Number 11500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Fever (1858)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

Pictures of the explanted valve were reviewed.Report of infection issue was unable to be confirmed through image evaluation.Image 1 and 2 showed the outflow aspect of an explanted valve.Image 3 showed the inflow aspect of an explanted valve.What appeared to be host tissue (minimal) overgrowth was noted on the stent circumference at both the inflow and outflow aspects.Suture holes were visible around the sewing ring.No other visible inconsistencies were observed from the valve.The device was not returned because it was sent for culture analysis to hospital pathology.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

Edwards received notification that a valve model 11500a25 implanted in the aortic position was explanted from a 48-year-old patient after an implant duration of six (6) months due to concerns of infection, however no endocarditis on the valve was suspected.Additionally, culture analysis was performed at hospital and pathology report came back negative from all culture growth after 10 days.Thus, there was no explanation of why the valve needed to be explanted.The patient presented with fever after an implant duration of sixty-seven (67) days and had multiple rounds of antibiotics which cured the patient.However, the fever returned and decision was made to explant the device.As reported, the patient had no signs of cardiac insufficiency and was not symptomatic.Additionally, the valve did not present regurgitation or stenosis, and at imaging tests it was shown to have normal functionality.The valve was explanted and another valve of the same model and size was implanted in replacement.At explant, the valve showed no signs of svd, no vegetations or abscesses.The patient was noted as to be recovering.

Manufacturer Narrative

Added information to section h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions) corrected data h6 (device code): "4001 - patient device interaction problem" code removed.H10: additional manufacturer narrative: the subject device was not returned for evaluation.The device history record (dhr) 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.There is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

• 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; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18805616
• MDR Text Key: 336509400
• Report Number: 2015691-2024-01445
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 48 YR
• Patient Sex: Male