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

Model Number 11500A23

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 11/22/2021

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 via the patient registry that a patient with a 23mm 11500a pericardial aortic valve underwent a redo aortic valve replacement procedure after an implant duration of 38 days due to unknown reasons.The explanted valve was replaced with a 27mm 11060a aortic valved conduit.The patient was noted to be in recovery post procedure.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.The root cause of this event cannot be conclusively determined with the available information.However, this event was most likely impacted by the progression of the patient's underlying pathologies.

Event Description

It was learned via the patient registry that a patient with a 23mm 11500a pericardial aortic valve was explanted after 38 days due to recurrent endocarditis.The explanted valve was replaced with a 27mm 11060a aortic valved conduit.The patient was noted to be in recovery post procedure.Through investigation, the patient has history of native aortic valve endocarditis (strep viridans) s/p avr with 23mm 11500a.Simultaneously, the patient underwent vsd repair , repair of mitral curtain and aortic annulus, and biatrial maze procedure with laa clipping.Follow-up tee showed severe aortic insufficiency, severe paravalvular leak related to aortic valve bioprosthetic dehiscence caused by recurrent endocarditis.The 23mm 11500a valve was explanted was replaced with a 27mm 11060a avc.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

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.H11 corrected data: based on the new information received, this event is no longer considered reportable.

• Brand Name: 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; 1 edwards way; irvine 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13978163
• MDR Text Key: 290560047
• Report Number: 2015691-2022-04763
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)250414(11)210415217825582
• 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,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2023

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 Model Number: 11500A23
• Device Catalogue Number: 11500A23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 05/18/2022; 02/22/2023
• Supplement Dates FDA Received: 05/21/2022; 03/20/2023
• Date Device Manufactured: 04/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 51 YR
• Patient Sex: Male