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

Model Number 8300AB25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Valve Stenosis (1717); Death (1802); Mitral Valve Stenosis (1965); Rupture (2208); Low Oxygen Saturation (2477); Multiple Organ Failure (3261)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation as it remained implanted.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.Av disruption (disassociation) is a dreaded and often fatal complication.This is an extreme form of posterior lv rupture where a portion or the entire posterior left atrium separates from the left ventricle.The risk of this occurrence is greatest in patients with extensive calcification in the posterior mitral annulus and leaflet.This finding is common in elderly patients undergoing mitral valve surgery and is evident by preoperative imaging, including echocardiography and cardiac catheterization.Chest computed tomography without intravenous contrast can be useful in quantifying the degree of posterior mitral annular calcification (also known as mac).Av disruption (disassociation) is usually related to vigorous traction or debridement of the posterior leaflet of the valve or to calcium excision in a calcified posterior leaflet.This can cause separation of the av groove, leading to massive hemorrhage upon separation from cardiopulmonary bypass.This complication is prevented by understanding the pathologic process of calcification of the mitral annulus and avoiding rupture by either placement of traction sutures on the edge of the posterior leaflet or by very careful calcium debridement only in isolated spots.A safer procedure may be to attach the prosthesis to the atrial wall, leaving the entire calcified mass intact.This approach may result in a smaller valve area but a successful operation.When this complication occurs, valve prosthesis is removed and the ventricle is reapproximated to the left atrium with felt strips.Often, a pericardial patch is used to cover the defect and the valve sutures are now placed into the pericardial patch.Nevertheless, this complication carries a high mortality.This case, a definitive root cause for the event cannot be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported via the implant patient registry that after a 25mm aortic valve was implanted.The patient required emergent re-exploration due to disruption of lv below the aortic valve annulus.The valve was removed, and d/t three large felt pledgets placed below the annulus, the valve could not be replaced.Therefore the intravalvular stent was removed, pledgeted suture was placed through the surgical cuff and the valve was seated and tied down.Per medical records, this case involves a (b)(6)-year-old male who presented with aortic and mitral stenosis.He underwent avr, mvr, and left atrial appendage ligation.Postoperatively, the patient became unstable and required re-exploration due to concern for av rupture.Upon evaluation, there was disruption of lv below the aortic valve annulus which required aortic valve revision and removal of the valve skirt.The 25mm valve was removed and three pledgeted sutures were placed in the area.Since large felt pledgets were placed below the annulus, the 8300ab valve could not be placed back.The intravalvular stent was removed, and the valve was seated and tied down.Post-op tee showed no perivalvular leak.The patient was transferred to the cticu in critical condition.The patient continued to be hemodynamically unstable.On pod #1, he was placed on va ecmo and developed multi-organ failure.On pod #2, his oxygenation continued to worsen and there was no improvement.Care was withdrawn and patient expired on pod #3.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

Reference: capa-20-00141.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; ms: mle-2; one edwards way; irvine CA 92614
• MDR Report Key: 8596880
• MDR Text Key: 144799726
• Report Number: 2015691-2019-01650
• 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
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2022
• 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; Required Intervention
• Patient Age: 70 YR