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

Model Number 11500A

Device Problems Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Aortic Regurgitation (1716); Death (1802); Edema (1820); Endocarditis (1834); Fever (1858); Hemorrhage/Bleeding (1888); Ischemia (1942); Pulmonary Insufficiency (2022); Staphylococcus Aureus (2058); Sepsis (2067); Malaise (2359)

Event Date 11/12/2018

Event Type  Death  

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.In this case, the root cause of the patient's endocarditis cannot be conclusively determined.However, there has been no indication or allegation of a malfunction contributing to this event.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification that an inpiris resilia valve was explanted due to endocarditis after an implant duration of approximately one month.The initial indication for replacement was a calcified bicuspid aortic stenosis.The patient was discharged to rehabilitation clinic at pod #6.Approximately one month after the surgery was readmitted due to fever and gastroinstentinal malaise.The hemoculture was (b)(6).The patient also presented vegetations on the aortic prosthesis and aortic regurgitation.The patient presented respiratory pulmonary insufficiency and edema and refractory sepsis and an emergency surgery was performed.The valve was found with leaflet vegetations and detachment and mitro-aortic continuity abscess with extensive tissue destruction.Redo-avr and aortic root replacement was performed.A pacemaker was implanted.The microbiology report showed that the subject device was (b)(6).The patient presented pneumonia, fever, perivalvular leaks, gastrointestinal bleeding and colonic ischemia.The patient expired 43 days after the initial replacement.

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: 8291085
• MDR Text Key: 134564508
• Report Number: 2015691-2019-00313
• 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
• Report Date: 01/11/2019

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: 01/31/2020
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 09/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 82