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

Model Number 11500A25

Device Problem Microbial Contamination of Device (2303)

Patient Problems Aortic Insufficiency (1715); Endocarditis (1834)

Event Date 07/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation due to endocarditis.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.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 could not 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 a 25mm valve was explanted due to bacterial endocarditis after 23 days of implant.As reported, there was aortic insufficiency that was not related with the bioprosthesis.The aortic arch was compromised and a conduit with a mechanical valve were implanted in replacement.The patient was reported to be hospitalized in stable condition.

Manufacturer Narrative

Additional manufacturer narrative: updated section.

Event Description

Edwards received notification that a 25mm valve was explanted due to bacterial endocarditis after 23 days of implant.As reported, the initial diagnosis for redo surgery was aortic insufficiency.Organism identified was staphylococcus.The patient had negative cultures even 5 days after the implant surgery when he was left the sicu unit.At explant, the valve was intact with no vegetation.There was a hole in the ventricle due to the endocarditis.The aortic arch was compromised and a conduit with a mechanical valve were implanted in replacement.The patient was reported hospitalized in stable condition.

Manufacturer Narrative

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

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; irvine
• MDR Report Key: 7739545
• MDR Text Key: 115705681
• Report Number: 2015691-2018-03093
• 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
• Report Date: 07/11/2018

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: 10/03/2019
• Device Model Number: 11500A25
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 07/27/2018; 07/23/2020
• Supplement Dates FDA Received: 08/20/2018; 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 79