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

Model Number 11500A23

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

Patient Problems Endocarditis (1834); Unspecified Infection (1930)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.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.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.A definitive root cause cannot be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification that this valve was explanted due to endocarditis with vegetation after 44 days of the implant.Patient had an infection with propionibacterium acnes and was reoperated in the context of septic shock.The endocarditis was very aggressive and even the tricuspid valve had vegetation.The patient did not have endocarditis pre-implant.No precipitating factors reported (no ppm implanted).It was reported that the patient was doing well after the replacement surgery.Taking into account that the patient had no symptoms within the first two weeks, the surgeon was concerned about the microorganism found because it is rare and grows slowly.P.Acnes has not been found elsewhere (instruments, and cpb circuits) although difficult to find something several weeks after.

Manufacturer Narrative

Additional manufacturer narrative: updated event information.

Event Description

Edwards received notification that this 23mm valve was explanted due to endocarditis with vegetation after 44 days of the implant.Patient had an infection with propionibacterium acnes with subannular abscess and was reoperated in the context of septic shock.The endocarditis was very agressive and even the patient presented vegetation at the annulus of the tricuspid valve (area of septal leaflet) and abscess.It was performed a perforation into right atrium for the ncc of the aortic valve (subannular).Debridement of septal leaflet (tv) which could be preserved.The patient did not have endocarditis pre-implant.No precipitating factors reported (no ppm implanted).A non-edwards aortic root bioprosthesis plus was implanted in replacement.It was reported that the patient was doing well after the replacement surgery.Taking into account that the patient had no symptoms within the first two weeks, the surgeon was concerned about the microorganism found because it is rare and grows slowly.

Manufacturer Narrative

H10: additional manufacturer narrative: image evaluation was performed.Report of endocarditis with vegetation could not be confirmed through image evaluation.Five color images were provided; two photos of outflow aspect of explanted valve and three photos of operative field.Explanted valve appeared reddish from blood.Per engineering evaluation, fmea line is appropriate.There are no similar complaints from the same lot as the subject event.Capa and pra are not required.

Manufacturer Narrative

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

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8861437
• MDR Text Key: 153387482
• Report Number: 2015691-2019-02854
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2021
• Device Model Number: 11500A23
• 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): Required Intervention