MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; REPLACEMENT HEART VALVE

Model Number 11500A23

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

Patient Problems Endocarditis (1834); Pneumonia (2011); Staphylococcus Aureus (2058); No Code Available (3191)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).Prosthetic endocarditis, with or without vegetation, of valves and annuloplasty rings is a serious complication of cardiac valve replacement and valve repair surgeries despite improvements in prostheses types, surgical techniques, and infection control measures.This infection is generally categorized into early (onset usually less than 60 days postoperative) and late (onset greater than 60 days post-implantation).Prosthetic endocarditis occurring within 60 days of valve or ring implantation generally reflects contamination arising in the perioperative period.There are many opportunities for organisms to seed a prosthesis peri-operatively, most of which probably occurs intraoperatively.Besides the patient's own skin and access lines, several other important modes of contamination have been recognized including air in the operating room, the coronary suction devices used during surgery and the heart-lung bypass machine, faulty technique during cardiac output measurements, and the prosthesis itself.In early cases of prosthetic endocarditis, subsequent infections are almost universally related to contamination at the time of surgery.The device was not returned for evaluation due to endocarditis.Based on the available information, the root cause for the endocarditis was likely due to patient related factors.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.A lot history review was performed and no events with the same defect were found.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

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.In this case, it was reported via the implant patient registry that a 23mm aortic valve, implanted for 24 days, was explanted due to bacterial endocarditis with vegetation.Per obtained medical records, the patient as diagnosed with bilateral pneumonias.Blood cultures grew out (b)(6).Panorex of teeth showed severe dental caries.The explanted device was successfully replaced with a 23mm bioprosthetic valve.The patient was discharged in stable condition on post-operative day eight.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8632959
• MDR Text Key: 145830544
• Report Number: 2015691-2019-01820
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

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 Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Model Number: 11500A23
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 10/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR