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

Model Number 8300AB25

Device Problems Perivalvular Leak (1457); Incomplete Coaptation (2507)

Patient Problems Aortic Regurgitation (1716); Atrial Fibrillation (1729); Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262); Vascular System (Circulation), Impaired (2572); Complete Heart Block (2627)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

Udi #: (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.Like mr, if the regurgitation worsens or becomes symptomatic, reoperation may be necessary.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.Pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bioprosthesis may not seat properly after debridement.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.In this case, the patient required intervention due to perivalvular leak after an implant duration of three (3) months.There was no reported malfunction of the device.The root cause of this event cannot be conclusively determined.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.There were no issues identified that would have impacted this event.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

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".The information reported may or may not be related to the edwards device.It was reported that this patient with a 25mm pericardial aortic valve underwent a valve-in-valve procedure after an implant duration of three (3) months due to significant paravalvular leak (pvl).The tavr procedure was performed with a 26mm edwards transcatheter valve.Per the medical records, prior to the tavr procedure, the patient was hypotensive (cardiogenic vs.Septic) and required vasopressor support.Significant pvl was observed and the patient was referred to cardiology for percutaneous closure of the pvl.The patient underwent percutaneous closure of the pvl using a 6mm vsd device and balloon aortic valvuloplasty (bav) with a 26mm z med balloon.Post bav, the patient had significant aortic regurgitation.It was decided to place a 26mm edwards transcatheter valve emergently.Post valve deployment, severe pvl remained, as such, the device was re-prepped with +2cc and re-inflated the balloon.Tee demonstrated mild to moderate pvl.The patient was transferred to the cicu after the procedure.Postoperatively the patient experienced a-fib and complete heart block.Ep was consulted and a permanent pacemaker was implanted on pod #1.The patient expired on pod #13.

Manufacturer Narrative

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: 8527459
• MDR Text Key: 142506583
• Report Number: 2015691-2019-01352
• 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,use
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2021
• Device Model Number: 8300AB25
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 79 YR