MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE DELIVERY SYSTEM; REPLACEMENT HEART VALVE

Model Number 8300DB23

Device Problems Break (1069); Crack (1135); Loose or Intermittent Connection (1371)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

The event is reported as a valve explant at implant.This is typically a result of inappropriate sizing, difficulty seating, valve displacement before or after frame expansion, or distortion of the valve during implantation and/or the patient¿s anatomy.Explants at implant are not typically related to a malfunction of the device.In this case, the surgeon alleged that the valve failed to deploy and a part of the failed device was found in the left ventricle.The surgeon had to go back on bypass to rectify this matter.Although there was no reported serious injury or death, the potential for serious injury in this case was not remote.The device is pending return.A root cause cannot be determined at this time.If new information is received or the device is returned for evaluation, a supplemental report will be submitted.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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 23mm valve.As reported, after placing the three guiding sutures and passing them through the valve, the valve was attempted to be lower with the holder inside the aortic route.At this point the valve came off the holder and all the transparent plastic pieces came apart.The valve was taken out of the aortic route and it was tried to connect the valve once again into the holder.The same process happened again and it felt as if the holder was loose and not holding the valve in situ.The valve was took out and passed it to the scrub nurse.The patient had a poor left ventricle so the surgeon did not want to try to use the same model valve again.A valve new 23mm was successfully implanted.After closing the aortotomy and before coming off bypass, the valve function was "tetsted" on toe.At that moment, a foreign object was noted in the left ventricle (lv).Immediately, the surgeon x-clamp the aorta and go back on bypass.The foreign object in the lv was the tip of the holder of the valve.The patient was well and ready to be discharged home.

Manufacturer Narrative

Evaluation summary: customer report of "valve came off the delivery system and all the transparent plastic pieces came apart" could not be confirmed through visual observations.As received(pre-deco), the delivery system had the valve with holder and balloon introducer attached, and the locking sleeve appeared to be locked.However, it was observed that the balloon introducer was not fully threaded into the holder.Consequently, the balloon introducer had slipped out of the holder during the decontamination process.Report of "issues with the preparation of the delivery system" was not confirmed.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 two of the three black stitch markings on the sewing ring; one hole near each mark.The returned insertion tool was connected to the returned balloon introducer.The balloon introducer was then able to fully thread into the holder of the returned valve.The valve was then able to be connected to returned delivery system and the locking sleeve locked into place.No issues were encountered during connection of the valve to the delivery system.Additional manufacturer narrative: per the engineering evaluation, it appeared that the root cause of the balloon introducer being dropped into the patient was most likely use error.The hospital staff likely did not have the balloon introducer correctly attached to the valve holder at time the valve was lowered into the patient.A definitive root cause for the valve detaching from the delivery system could not be conclusively determined, but it also may have been due to use error.It is possible that the locking sleeve was not fully advanced.The ifu provides adequate instructions to complete these steps.There are no findings from product evaluation to confirm a manufacturing defect.No further action is required.

Manufacturer Narrative

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

• Brand Name: EDWARDS INTUITY ELITE DELIVERY SYSTEM
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8167114
• MDR Text Key: 131305077
• Report Number: 2015691-2018-05305
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2018

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: 04/29/2020
• Device Model Number: 8300DB23
• Device Catalogue Number: 8300DB23
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 61