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

Model Number 11500A

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

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

Event Date 11/22/2023

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 21mm 11500a aortic valve was explanted after an implant duration of 1 years, 11 months due to unknown reason.The explanted valve was replaced with a 21mm 11500a 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.

Event Description

It was learned through implant patient registry and medical records that a patient with a 21mm 11500a aortic valve in aortic position was explanted after an implant duration of 1 years, 11 months and 27 days due to e.Faecalis endocarditis with ai.The explanted valve was replaced with a 21mm 11500a valve.Per medical records: the patient presented with fever, malaise and dizziness, c/o blurry vision and headaches.Patient diagnosed with sepsis, dka.Blood cultures positive for e.Faecalis.The patient started antibiotic treatment.An echo demonstrated a possible aortic valve lesion, tee demonstrated possible aortic root abscess aortic prosthesis appeared intact without vegetation, small possible vegetation on the native mitral valve.Coronary cta findings consistent with recurrent aortic valve endocarditis with vegetations on the aortic, a mitral valves and hypodense areas on aortic root.The patient was transferred to tertiary center for surgery given concern for aortic root abscess and involvement of the aorto-mitral curtain.The patient underwent redo sternotomy, extensive aortic root debridement, due to an extensive root abscess with frank purulent material, a bentall procedure, aortic root reconstruction using bovine pericardium, implant of a 21mm 11500a aortic valve lnspiris valve and graft and coronary reimplantation.Post cbp tee showed normal lvef 60-65%, a well seated av , no pvl and no intravalvular ar, mean gradient 12mm hg.

Manufacturer Narrative

Prosthetic endocarditis is a serious complication of valve replacement and repair surgeries despite improvements in prostheses types, surgical techniques, and infection control measures.This infection is generally categorized into early (onset at 60 days or less postimplant) and late (onset greater than 60 days post-implant).Early-onset generally reflects contamination arising in the perioperative period; if there were ever non-conformances in the sterility or packaging processes, they would most likely manifest at this time.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.In this case the onset was greater than 60 days post-implant.Corrected data: based on the additional information, this event is no longer considered reportable.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 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: 18384292
• MDR Text Key: 331289244
• Report Number: 2015691-2023-18736
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• 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: 12/27/2023
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 49 YR
• Patient Sex: Male