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

Model Number 11500A21

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

Patient Problems Endocarditis (1834); No Code Available (3191)

Event Date 09/08/2019

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Although bioprosthetic valves have been proven to have excellent long term durability, failure does occur in a small number of valves.Failure of a bioprosthetic valve over time is more likely due to structural valve deterioration (svd) which occurs as a result of stenosis (from calcification or host tissue overgrowth), dehiscence, fibrosis, non-calcific degeneration and/or endocarditis.In this case, minimal information regarding this explant procedure was received and attempts to get additional information regarding the condition of the device, device return status, patient's medical history, or possible comorbidities have been unsuccessful.If new information becomes available, a supplemental report will be submitted.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.

Event Description

Edwards received information through its implant patient registry that a 21 mm aortic pericardial valve was explanted after a duration of twenty three (23) days due to unknown reason.A 21 mm edwards' valve was implanted in replacement.There was no allegation of device malfunction.It was unknown if the device will be returned at this time.

Event Description

Edwards received information through its implant patient registry that a 21mm aortic pericardial valve, implanted twenty three (23) days, was explanted for a bentall surgery.This device was originally implanted for bentall surgery.On postoperative day twenty three (23), infection was detected on the graft area and re-bentall surgery was performed.Although there was no infection or endocarditis observed on this valve, since bentall surgery was performed, this device was replaced with a 21mm edwards valve.The patient status was reported as ¿recovered¿.The device was not returned for evaluation as it was discarded at the hospital.There was no allegation of device malfunction.Type and source of infection were not reported.

Manufacturer Narrative

H10.Additional manufacturer narrative: edwards received additional information through follow up with the healthcare provider.In this case, the device was not returned due to infection.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.If there were ever non-conformances in the sterility or packaging processes, they would most likely manifest in the early post-operative period.In this case, onset of endocarditis of the newly implanted valve or ring occurred within 60 days of implant.Based on the available information, the root cause of the event remains indeterminable was likely due to patient related factors and procedural factors.A lot history review was performed, and no events with the same defect were found.

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: 9272106
• MDR Text Key: 164883068
• Report Number: 2015691-2019-04086
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2020
• Device Model Number: 11500A21
• 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: 76 YR