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

Model Number 8300AB

Device Problems Perivalvular Leak (1457); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.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 lifesciences will continue to monitor all reported events.

Event Description

It was reported through implant patient registry that a patient originally implanted with a 25mm aortic valve for 1 year and 1 month underwent an explant procedure for unknown reasons.The patient received a replacement 25mm aortic valve.The patient final disposition is unknown.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".

Manufacturer Narrative

Additional manufacturer narrative: updated sections event, other relevant history,(expiration date), event problem codes, device manufacture date, and adverse event problem.Udi #(b)(4).The device was not returned to edwards for evaluation as it was discarded.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.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.While the majority of affected patients are asymptomatic, it can lead to significant morbidity including heart failure and hemolytic anemia.Pvl can occur in the mitral and aortic position for similar reasons, including technique and patient related factors.The type and cause of regurgitation varies depending upon multiple factors.Typically, mild regurgitation is not unusual after initial valve replacement, and is usually tolerated by patients.Often moderate to high regurgitation requiring re-operation in the immediate post-operation period is due to procedural related issues and is unrelated to the device.Regurgitation which develops progressively over time can be due to number of issues including patient related factors or structural valve deterioration.A definitive root cause could not be determined; however, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported through implant patient registry that a 25mm aortic valve implanted for 1 year and 1 month was explanted due to severe perivalvular leak.The patient received a 25mm aortic valve in replacement.There was no regurgitation post implant.The patient was transferred to the intensive care unit in guarded condition.The patient was discharged in stable condition on pod #4.

Manufacturer Narrative

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

• 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: 8233142
• MDR Text Key: 132585380
• Report Number: 2015691-2019-00128
• 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: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2018

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: 03/11/2021
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 01/03/2019; 07/23/2020
• Supplement Dates FDA Received: 01/18/2019; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR