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

Model Number 8300AB

Device Problems Perivalvular Leak (1457); Material Puncture/Hole (1504)

Patient Problems Aortic Insufficiency (1715); Failure of Implant (1924); Insufficiency, Valvular (1926); No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: customer report of perivalvular leak could not be confirmed through visual observations.X-ray demonstrated wireform intact and frame expanded.Customer report of "hole in one of the leaflets" confirmed through visual observations.Leaflet 2 had a perforation which measured approximately 2mm x 4mm in size.The damage was beveled at the outflow aspect and had similar characteristics to those caused by suture tail abrasion.Suture did not remain attached to the sewing ring at the black stick marking near leaflet 2, however the leaflet damage aligned with black stitch marking.Suture was still attached to black stitch marking near leaflet 1.And suture holes were visible near the black stitch marking near leaflets 2 and 3, one suture hole near each.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.Pvl can occur in the mitral and aortic position for similar reasons.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.In this case, the explanted device was replaced with another edwards valve, one size larger.The reported leaflet damage was also found to be from suture tail abrasion which is caused by excess sutures.Per the device instructions for use, "it is important to cut the sutures close to the knots and ensure that exposed suture tails will not come into contact with the valve leaflet tissue to prevent wear due to contact with the sutures." edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.Udi #: (b)(4).

Event Description

It was reported that an 8300ab 21mm intuity elite aortic valve, with implant duration of two (2) months, was explanted due to perivalvular leak (pvl) at the right and non-coronary commissure.Upon explant, there was a visible hole in one of the leaflets.This was in conjunction with the pvl.The explanted device was replaced with an 11500a 23mm inspiris resilia valve.

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.

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: 8434904
• MDR Text Key: 139289738
• Report Number: 2015691-2019-00932
• Device Sequence Number: 0
• Product Code: LWR
• 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: 02/22/2019
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2020
• Device Model Number: 8300AB
• Device Lot Number: R-18B0516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR