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

Model Number 8300AB21

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

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 four months.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) could not be reviewed, as the device serial number was not provided.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 received notification that this patient with 21mm aortic pericardial valve had a re-operation for a balloon procedure (post-dilation) due to perivalvular leak (pvl) between the right and the non-coronary sinus after an implant duration of approximately four (4) months.The valve was expanded with a 23mm true balloon and the pvl was reduced to trivial, with a presence of a trivial central jet.No other information was provided.

Manufacturer Narrative

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.

Event Description

Edwards received notification that this patient with 21mm aortic pericardial valve had a re-operation for a balloon procedure (post-dilation) due to perivalvular leak (pvl) between the right and the non-coronary sinus secondary to valve under expansion after an implant duration of approximately four (4) months.Through the review of the article 'percutaneous treatment of paravalvular leak in rapid deployment bioprosthetic aortic valve with balloon dilation' it was learnt that the intraoperative echocardiogram showed a bioprosthesis valve malapposition with only a trivial paravalvular leak.A transthoracic echocardiogram revealed a moderate-to-severe (3+/4+) aortic regurgitation caused by an anterior leak.Subsequent cardiac computed tomography suggested that the leak was secondary to a poorly apposed valve stent due to under sizing and slight oblique orientation in the aortic root.The valve was expanded with a 23mm true balloon and the pvl was reduced to trivial, with a presence of a trivial central jet.Echocardiographic stability was confirmed at two (2) months follow-up.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections b5, h6.

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: 8802598
• MDR Text Key: 151442088
• Report Number: 2015691-2019-02633
• 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,Followup,Followup
• Report Date: 06/27/2019

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: 03/20/2022
• Device Model Number: 8300AB21
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 08/08/2019; 08/06/2020; 10/09/2020; 07/23/2020
• Supplement Dates FDA Received: 08/26/2019; 08/24/2020; 10/14/2020; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR