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

Model Number 11500A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information are in process.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.Based on the information received the cause of the event cannot be determined.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

It was reported a patient initially implanted with a 21mm aortic valve for 3 months 28 days, had an explant procedure for unknown reasons.A 23mm surgical valve was implanted in the patient.The current patient status is unknown.

Event Description

It was reported that a patient implanted with a 21mm aortic valve for 3 months 28 days had an explant procedure due to endocarditis.The patient presented with new vegetation on the aortic and mitral valves.As the patient had symptoms of a recent embolic event, the patient was brought to the operative room for the high-risk surgical procedure.The entire aortic valve was resected with what appeared to be either abscess or destruction of the annulus into the level of the coronary ostia.The patient underwent total root replacement with a 23mm valve and 28mm valsalva graft.The native mitral valve was patched with bovine pericardial patch.Cabgx3 was performed.Intra-aortic balloon pump was placed.Eventually, the patient weaned off cardiopulmonary bypass with significant inotropic and vasopressor support.The patient expired in the operating room.

Manufacturer Narrative

Prosthetic endocarditis with or without vegetation, of valves and annuloplasty rings is a serious complication of 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).Late prosthetic endocarditis resembles native valve endocarditis in terms of etiological microbes, and sources of contamination are presumably similar.Late endocarditis occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the body.Dental, genitourinary, and gastrointestinal manipulation are known causes of transient bacteremia, which can place a patient at risk for prosthetic endocarditis.Additional procedures placing patients at risk for prosthetic endocarditis include urethral catheterization, colonoscopy, barium enemas, and surgical procedures.Late prosthetic endocarditis is not in any way related to the sterilization or packaging process of the device.A definitive root cause could not be determined; however, it is likely that patient related factors contributed to the event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

• 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: 8812607
• MDR Text Key: 151758494
• Report Number: 2015691-2019-02695
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR