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

Model Number 8300DB19

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: balloon bursts may occur during valve deployment and would typically be the result of sub-annular calcification or less commonly a malfunction of the balloon.If this occurs, the surgeon will be unable to achieve the required inflation pressures to fully expand the frame.It will be detected by the surgeon and will require exchange of the device.The root cause of this event cannot be conclusively determined with the available information.The subject device was requested to be returned for evaluation.If returned and evaluated, a supplemental report with findings will be submitted.The device history record (dhr) was not 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

It was reported that the balloon of the delivery system had ruptured during the implant of an 8300ab pericardial aortic valve of unknown size.The valve was implant and snared.Upon inflating the balloon, the balloon would not maintain pressure.The surgeon had discovered a hole at the base of the balloon under the sewing ring.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

Event Description

It was reported that the balloon of the delivery system had ruptured during the implant of a 21mm 8300ab pericardial aortic valve.The valve was implant and snared.Upon inflating the balloon, the balloon would not maintain pressure.The surgeon had discovered a hole at the base of the balloon under the sewing ring.The surgeon has performed over 75 intuity implants and the most experienced pa prepped the valve for implant.

Manufacturer Narrative

H10: additional manufacturer narrative: the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.

Manufacturer Narrative

Evaluation summary: customer report of delivery system balloon rupture was confirmed.As received, the balloon introducer and valve holder remained attached to the delivery system with locking sleeve engaged.All three green sutures were cut at the cutting channels of the valve holder and valve was not returned.The returned delivery system was in the advanced position as received.The balloon of the delivery system was found leaking near the proximal end where the blue sleeve is when inflated with water per ifu instructions.Atrion inflation syringe was also returned and no visible inconsistencies were observed.

Event Description

It was reported that the balloon of the delivery system had ruptured during the implant of a 21mm 8300ab pericardial aortic valve.The valve was implant and snared.Upon inflating the balloon, the balloon would not maintain pressure.The surgeon had discovered a hole at the base of the balloon under the sewing ring.Per the sales rep, the balloon would not fill until 'the surgeon took the device from the tech and had to fiddle with it'.The surgeon has performed over 75 intuity implants and the most experienced pa prepped the valve for implant.

Manufacturer Narrative

H11: corrected data: additional information obtained confirmed that the previously reported event had no serious injury identified during the event.As such, this event is no longer considered reportable and this correction is being submitted.

Event Description

It was reported that the balloon of the delivery system (21mm 8300db) leaked during the implant of a 21mm 8300ab pericardial aortic valve.The balloon had a slow leak from the start of the case and would not maintain pressure.The surgeon discovered a hole at the base of the balloon under the sewing ring.However, he was able to extend the stent and implant the device.No information was provided regarding patient/procedural outcome.The surgeon has performed over 75 intuity implants and the most experienced pa prepped the valve for implant.Per product eval: customer report of delivery system balloon leakage was confirmed.Per engineering eval: based on the sem analysis and feedback from manufacturing the balloon was most likely cut by a sharp surgical instrument during customer use/handling.It is unlikely this type of cut could have been made during manufacturing or packaging.

Manufacturer Narrative

H10: additional manufacturer narrative: there are instances where the user experiences difficulty in the use of the inflation device during implant of an intuity elite valve.This can include, but not limited to, inflation difficulties, pressure gauge not reading, difficult to use, or damaged.These events will only be reportable if the event caused or contributed to a serious injury or death.In this case, during implant of the valve the delivery system balloon was leaking due to a hole found in the base of the balloon.No serious injury was identified during this event.

• 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: 10329657
• MDR Text Key: 201873373
• Report Number: 2015691-2020-12719
• 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,user faci
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8300DB19
• Device Catalogue Number: 8300DB19
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR