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

Model Number 8300DB25

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191); Activation Problem (4042)

Patient Problem No Code Available (3191)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the device has been received and is pending evaluation.The device has been returned for evaluation and is pending evaluation.The device history record was reviewed and shows that this device met all manufacturing specifications for product release for distribution.No issues were identified that would have impacted this event.Based on the information received the cause of the event cannot be determined.A supplemental mdr will be submitted when additional information is available.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received notification of an aborted attempt to implant a 25mm aortic valve due to inability to deploy the valve.Procedure done in ministernotomy.As reported, after placing the three guiding nadir sutures and passing them through the valve, it was attempted to lower the valve with holder inside the aortic root.At this point, the valve came off the holder and the transparent plastic piece came apart (the smaller part of the insertion tool that stays in valve to allow the delivery holder with balloon to be attached to the valve, see picture attached).The valve was took out off the root and it was tried to connect the valve once again into the holder.They tried to lower the valve but the issue occurred again.It was felt that the holder was loose and not holding the valve in-situ.The surgeon was feared that the plastic piece could fall into the left ventricle and decision to removed the valve was made.A new valve same model and size 25mm aortic valve was deployed and implanted successfully.The patient was discharged on pod+2 without any adverse events reported.

Manufacturer Narrative

The valve was received with the holder attached.All three leaflets were rigid and transparent-like due to dehydration.The x-ray demonstrated the wireform to be intact and the frame remained crimped.Suture holes were visible near all three black stitch markings on the sewing ring; one hole near each mark.Lab sample insertion tool, balloon introducer, and 25mm delivery system were used for evaluation purposes.The balloon introducer was able to thread into the holder of the returned valve.The valve was then able to be connected to the 25mm delivery system.No issues were encountered during connection of the returned valve to the lab sample delivery system.Customer report of "valve came off the holder and the transparent plastic piece came apart" was unable to be confirmed; insertion tool, balloon introducer, and delivery system were not returned.Report of "inability to deploy the valve" is unable to be confirmed through visual observations.Based on the information received the cause of the event cannot be conclusively determined.Edwards lifesciences will continue to monitor all reported events.If any new information is received, a supplemental report will be submitted accordingly.No further actions are required at this time.

Event Description

Edwards received notification of an aborted attempt to implant a 25mm aortic valve due to inability to deploy the valve.Procedure done in ministernotomy.As reported, after placing the three guiding nadir sutures and passing them through the valve, it was attempted to lower the valve with the delivery system inside the aortic root.At this point the valve came off the delivery system and the transparent plastic piece came apart (the smaller part of the insertion tool that stays in valve to allow the delivery system with balloon to be attached to the valve, see picture attached).The valve was took out off the root and it was tried to connect the valve once again into the delivery system.They tried to lower the valve but the issue occurred again.It was felt that the delivery system was loose and not holding the valve in-situ.The surgeon was feared that the plastic piece could fall into the left ventricle and decision to removed the valve was made.A new valve same model and size 25mm aortic valve was deployed and implanted successfully.The patient was discharged on pod+2 without any adverse events reported.

Manufacturer Narrative

Corrected data: f10,h6.Reference capa-20-00141.

• Brand Name: EDWARDS INTUITY ELITE DELIVERY SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8165829
• MDR Text Key: 131332297
• Report Number: 2015691-2018-05289
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2022
• Device Model Number: 8300DB25
• Device Catalogue Number: 8300DB25
• Device Lot Number: 5821128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 99