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

Model Number 11500A25

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Anemia (1706); Bacterial Infection (1735); Death (1802); Endocarditis (1834); Fever (1858); Sepsis (2067); Blood Loss (2597)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

(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 and procedural 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 25mm aortic valve, implanted for 2 months and 11 days, was explanted due to endocarditis ((b)(6) bacteremia), vegetation, and annular abscess.Per obtained medical records, the patient presented on postoperative day 44 from the initial implant procedure with fever vomiting, sternal wound dehiscence, and sepsis.The patient underwent sternal wound debridement and washout.The patient was found to have native mitral valve endocarditis.The patient then underwent aortic valve replacement with a 23mm aortic valve, the chest was left open.The patient also was found to have ischemic bowel.A jejunojejunostomy was performed with abdominal closure.The patient developed acute liver failure with elevated liver enzymes.Has required multiple blood and blood products transfusions for acute blood loss anemia.Neurology was consulted due to persistent unresponsiveness and the patient expired on pod #12.

Manufacturer Narrative

Additional manufacturer narrative: updated coding.

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: 9418946
• MDR Text Key: 169563256
• Report Number: 2015691-2019-04483
• 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,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2021
• Device Model Number: 11500A25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR