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

Model Number 11500A

Device Problems Gradient Increase (1270); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Endocarditis (1834)

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional narrative.The subject device is not available for evaluation as it remains implanted in the patient.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 56-years-old patient with a 21mm inspiris resilia valve implanted in the aortic position experienced with high gradients after six (6) months of implant duration.As reported, post operative tee showed well functioning of the aortic valve prosthesis (mean pressure gradient 12mmhg, lvef normal).On 2d echo performed on post-operative day 5, the valve showed mean pressure gradient of 11mmhg, no aortic regurgitation, ac +, lvef 60%.The patient was discharged in stable condition on post-operative day 7.However, at six (6) month follow-up echo, the mean gradient was 40mmhg and the patient was experiencing shortness of breath.As reported, endocarditis was ruled out in culture report.However, the patient was placed under antibiotic treatment and would undergo a check-up the following month.

Manufacturer Narrative

Initially, it was reported that this 21mm inspiris resilia valve implanted in the aortic position experienced with high gradients after six (6) months of implant duration.However, through investigation it was learned that this valve presented endocarditis.Prosthetic endocarditis is a serious complication of valve replacement and repair surgeries despite improvements in prosthesis types, surgical techniques, and infection control measures.This infection is categorized into early (onset at 60 days or less post-implant) and intermediate/late (onset greater than 60 days post-implant).Intermediate/late onset occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the body and is not related to the sterilization or packaging process.The reported event is a device issue related to patient factors without evidence or allegation of a malfunction which could be related to a manufacturing non-conformance.There is no evidence of product failure with regard to design, reliability, or use error.In addition, the event does not allege a labeling non-conformance/deficiency, a use-related issue with a hazardous situation, or a device related infection.Based on the information available, the most likely cause is patient factors.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Manufacturer Narrative

Added information to section b5 (describe event or problem).H10: 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

Edwards received notification that a 56-years-old patient with a 21mm inspiris resilia valve implanted in the aortic position experienced with high gradients after six (6) months of implant duration.As reported, post operative tee showed well functioning of the aortic valve prosthesis (mean pressure gradient 12mmhg, lvef normal).On 2d echo performed on post-operative day 5, the valve showed mean pressure gradient of 11mmhg, no aortic regurgitation, ac +, lvef 60%.The patient was discharged in stable condition on post-operative day 7.However, at six (6) month follow-up echo, the mean gradient was 40mmhg and the patient was experiencing shortness of breath.As reported, endocarditis was ruled out in culture report.However, the patient was placed under antibiotic treatment and started anticoagulation medicines.The patient would undergo a check-up the following month.

• 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: 18063712
• MDR Text Key: 327241816
• Report Number: 2015691-2023-17239
• 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,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 65 KG