MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; TISSUE, HEART-VALVE

Model Number 8300AB

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

Additional 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.If additional information is received a supplemental mdr will be submitted.No further corrective, or preventative actions are required at this time.Edwards life sciences will continue to monitor all reported events.

Event Description

It was reported that a 25mm valve implanted for two years, eight months was explanted due to unknown reasons.A 25mm valve was implanted in replacement.

Event Description

It was reported that a 25mm 8300ab valve implanted for two years, five months was explanted due to endocarditis and vegetation.A 25mm 11500a valve was implanted in replacement.The patient tolerated the procedure well and was transferred to the cardiothoracic intensive care unit in stable condition.The patient was discharged home on pod #14.Per the records, the patient had positive blood culture (strep mitis) on (b)(6) 2020; however, tee done showed no vegetations but thickening of av prosthetic cusps.Repeat cultures on (b)(6) 2020 were negative.On (b)(6) 2020, the patient presented to hospital after experiencing visual disturbances which he described as l tunnel vision which progressed to involve the l temporal side.He was found to have an occipital stroke thought to be secondary to septic emboli from strep viridans (mitis) prosthetic valve infective endocarditis, dental source after recent root canal.The patient completed a six week course of antibiotics.Tee done on (b)(6) 2020 showed lv systolic function with an ef of 55-60% with cusps of the aortic valve bioprosthesis continued to be diffusely thickened.There was a highly mobile 9 mm long echogenic density on the non coronary cusp consistent with a vegetation.

Manufacturer Narrative

H10: additional manufacturer narrative: based on the additional information obtained, this event is no longer considered reportable.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 at 60 days or less post-implant) and late (onset greater than 60 days post-implant).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 after 60 days is not related to the sterilization or packaging process of the device.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11023960
• MDR Text Key: 222011138
• Report Number: 2015691-2020-15056
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2021
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR