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

Model Number 11500A

Device Problems Microbial Contamination of Device (2303); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/26/2023

Event Type  Injury  

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

It was learned through implant patient registry that a patient with a 29mm 11500a aortic valve implanted in the tricuspid position was explanted after an implant duration of two (2) years, ten months due to unknown reasons.The explanted valve was replaced with a 27mm 11060a aortic valve.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

(type of investigation, investigation findings, and investigation conclusions).H11: corrective data: based on the additional information obtained, this event is no longer considered reportable, and this correction is being submitted.All pertinent information available to edwards lifesciences has been submitted.

Event Description

It was learned through implant patient registry that a patient with a 29mm 7300tfx mitral valve implanted in the tricuspid position was explanted after an implant duration of one (1) year, five months and 22 days due to mssa endocarditis.The explanted valve was replaced with a 27mm 11400m mitris valve.Per medical record, the patient was on methadone, recent iv fentanyl, patient presented to ed, ekg sr with rbbb, blood cultures were positive for mssa.The patient was diagnosed with tricuspid endocarditis, treated and completed a long course of antibiotics.Skin cultures prior to surgery showed sub epithelial micro abscesses consistent with septic vasculitis.An echo post antibiotic treatment showed a moderate/large mobile vegetation on the tv remains and there is increasing now moderate tr.The patient underwent redo tvr.The explanted valve was noted to have purulent material along the posterior leaflet territory.The patient was transported to cv icu in stable condition.An echo on pod #13 showing normal rv function, ef 55 to 60%.The patient was discharged on pod #17 on antibiotics for chronic suppression of heart valve infection.

Event Description

It was learned through implant patient registry that a patient with a 29mm 7300tfx mitral valve implanted in the tricuspid position was explanted after an implant duration of one (1) year, five months due to unknown reasons.The explanted valve was replaced with a 27mm 11400m mitris valve.The implantation data card indicated that the device explant was not due to deficiency of the original device.

Manufacturer Narrative

H11: corrective data: the device information previously submitted under medwatch # 42252 was incorrect.Based on the additional information obtained, the information has been updated accordingly.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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18576787
• MDR Text Key: 333659479
• Report Number: 2015691-2024-00572
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057
• 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,Followup
• Report Date: 03/14/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male