MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; TISSUE, HEART-VALVE

Model Number 8300AB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endocarditis (1834); Complete Heart Block (2627)

Event Date 12/25/2019

Event Type  Injury  

Manufacturer Narrative

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 occurs at 60 days or less post-implant) and late (onset greater than 60 days post-implant).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.In early cases of prosthetic endocarditis, subsequent infections are almost universally related to contamination at the time of surgery.If there were ever non-conformances in the sterility or packaging processes, they would most likely manifest in the early post-operative period.The device was not returned for evaluation, as it was infected with endocarditis.The root cause of this event cannot be conclusively determined.However, it is likely that patient related and/or procedural factors contributed to the event.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.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.Udi number: (b)(4).

Event Description

It was reported via patient registry that a patient with a 21mm aortic valve expired after an implant duration of 3 months due to unknown cause of death.Per index medical records, patient presented with stenosis and underwent avr for mssa endocarditis secondary to an av fistula infection.A post-implant tee demonstrated a prosthesis with normal function and no regurgitation.Patient developed complete heart block post-operatively and only required temporary pacemaker.Patient was discharged home on pod #5.Per recent h&p about 2 months after the avr procedure the patient developed large, multilobulated, pedunculated, and highly mobile echodensity in the svc-ra junction concerning for vegetation near a left-sided jugular hemodialysis catheter tip.Antibiotic therapy was initiated for the mrsa bacteremia and candida fungemia, and they were discharged after 15 days.Six days later, the patient was readmitted for hypertensive crisis, and fevers, treated and released home two days later.Approximately two weeks later, the patient expired due to unknown reasons.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

H10: additional manufacturer narrative.Updated h6 per new information received.

Event Description

It was reported via patient registry that a patient with a 21mm aortic valve expired after an implant duration of 3 months due to unknown cause of death.Per index medical records, patient presented with stenosis and underwent avr for mssa endocarditis secondary to an av fistula infection.A post-implant tee demonstrated a prosthesis with normal function and no regurgitation.Patient developed complete heart block post-operatively and only required temporary pacemaker.Patient was discharged home on pod #5.Per recent h&p about 2 months after the avr procedure the patient developed large, multilobulated, pedunculated, and highly mobile echodensity in the svc-ra junction concerning for vegetation near a left-sided jugular hemodialysis catheter tip.Antibiotic therapy was initiated for the mrsa bacteremia and candida fungemia, and they were discharged after 15 days.Six days later, the patient was readmitted for hypertensive crisis, and fevers, treated and released home two days later.Approximately two weeks later, the patient expired due to unknown reasons.There was no investigational evidence of prosthetic valve endocarditis, rather, it was a non-device related bacteremia and fungemia caused by the hemodialysis catheter.

Manufacturer Narrative

H10: additional manufacturer narrative.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10836966
• MDR Text Key: 216323239
• Report Number: 2015691-2020-14370
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR