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

Model Number 8300AB23

Device Problem Perivalvular Leak (1457)

Patient Problems Aortic Insufficiency (1715); Infarction, Cerebral (1771)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).Aortic regurgitation (ar) in bioprosthetic heart valves, also known as aortic insufficiency, occurs when the valve does not close properly in diastolic phase, which results in retrograde flow of blood into the left ventricle.Trivial/trace to mild amounts of ar are not unusual post operatively in bioprosthetic valves.This is usually tolerated by the patients.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, pvl, when severe, can lead to significant morbidity including heart failure and hemolytic anemia.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Under sizing can lead to a gap between the annulus and sewing ring since the valve implanted is too small in relation to the annulus.The use of pledgeted sutures during aortic valve replacement was thought to decrease the incidence of pvl.However, recent studies have concluded that non-pledgeted suture techniques offer an equivalent alternative to the traditional use of pledgets during aortic valve replacement, with no increase in pvl rates.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.The annulus is not a static structure and has dynamic characteristics which have been shown to play a critical role in valve function and efficiency.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.Edwards conducts manufacturing and inspection tests to ensure optimum functionality of each valve prior to final distribution.Such tests used to evaluate if edwards' valves meet specification include forward flow testing to determine the pressure gradient across the open valve and a coaptation test under constant hydrostatic back pressure to visually evaluate the coaptation of the leaflets.There was no reported malfunction of the device.The root cause of this event cannot be conclusively determined with the available information.It is unknown whether patient and/or procedural related factors may have caused or contributed to the reported issue.The subject device is not available for evaluation as it remains implanted in the patient.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that this patient with an 8300ab 23mm intuity elite aortic valve implanted had pvl and possible stroke.The patient's echo revealed a mild paravalvular leak (pvl).The patient's surgeon plans to assess in 2-3 months for any possible reintervention.Per received medical records, multifocal cerebral infarction has been observed and is being medical treated for possible seizure activity.

Event Description

Updated information received indicated that this patient had a secondary procedure completed to treat the moderate pvl associated with the 23mm 8300ab aortic valve.A 23mm true balloon was inflated inside the valve to further expand it.Following this, tee performed showed the sealing of the leak with no significant pvl.It was suspected that a piece of calcium broke off inside the annulus causing the pvl.The procedure was concluded and the patient was transferred to the icu in stable condition.Per received medical records, multifocal cerebral infarction has been observed and was medically treated for seizure activity.Ct head showed no acute intracranial abnormality.Patient received increased does of keppra and did not have any recurrent seizures.

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: 9511671
• MDR Text Key: 175177746
• Report Number: 2015691-2019-04877
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2021
• Device Model Number: 8300AB23
• Device Lot Number: 5242369
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 66