MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750CM26A

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral tavr procedure for a 26mm sapien 3 valve, there was difficulties withdrawing the delivery system and crimped valve into the esheath.The devices were removed as a unit, but the valve dislodged from the balloon.The valve would not cross the native annulus.The team tried to change the angle and added 1cc to the balloon, but were not successful.It was decided to remove the devices in order to perform a bav.However, they were not able to get the valve all the way back into the esheath.The team removed the devices as one unit, but the system got 'stuck' right at the level of the skin, and the physician pulled the system.The system and esheath exited the body, but the valve came off of the delivery system and was left in the body, right under the skin at the access site.The valve was removed with hemostats; a 16fr was inserted for hemostasis.A bav was done and a 2nd valve was used and implanted without issue.The vascular surgeon was called and repaired the vessel.The patient is stable and doing well.

Manufacturer Narrative

Correction to h6 based on additional information received.The device was not returned to edwards lifesciences for evaluation, however, a device history record (dhr) review was done, and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.Imagery was provided by the facility for evaluation and the following was observed: the patient's native valve was calcified, the right access vessel was tortuous, and after removal of the devices, the valve remained under the skin at the access site.The following instructions for use (ifu) were reviewed: ifu for commander delivery system, device preparation manual, and procedural training manual.Based on this review, no ifu/training deficiencies were identified.The complaints for difficulty to withdraw system with valve through the esheath and thv dislodged off balloon were confirmed by the provided imagery.However, the complaint for difficulty to cross the native annulus was unable to be confirmed as applicable procedural imagery was not provided.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, based on a review of the dhr, complaint history, and lot history, there is no evidence to confirm that a manufacturing non-conformance contributed to the complaint.A review of ifu/training materials revealed no deficiencies.The complaint description states, 'the valve would not cross the native annulus.' as per the provided imagery, the patient's native valve was calcified.It is possible that presence of calcification in the annulus obstructed the valve from being placed in the annulus, causing difficulty in advancing the valve to the annulus.Available information suggests that patient factors (calcification) may have contributed to the complaint event.The complaint description states, 'the team removed the devices as one unit, but the system got 'stuck' right at the level of the skin, and the physician pulled the system.The system and esheath exited the body, but the valve came off of the delivery system and was left in the body right under the skin.The valve got caught on the perclose suture inside the vessel.They pulled too hard and the perclose suture broke/tore the vessel.' patient imagery revealed tortuosity of the right access vessel.The presence of tortuosity can result in the creation of sub-optimal angles during delivery system withdrawal that may lead to non-coaxial alignment.Such non-coaxiality can contribute to withdrawal difficulties as the valve likely caught on the esheath tip, resulting in the shifting of the valve toward the distal tip.Additionally, the valve caught on the sutures of perclose device.If the valve was not withdrawn completely into the valve before the unit is withdrawn from the patient, the valve is exposed and may catch on the sutures, resulting in the valve dislodgment from the balloon.Available information suggests that patient (tortuosity) and procedural factors (interaction with sutures) may have contributed to the complaint event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective and preventative actions nor a product risk assessment (pra) are required at this time.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12410564
• MDR Text Key: 270067192
• Report Number: 2015691-2021-04956
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)230302(10)63675158
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: 9750CM26A
• Device Catalogue Number: 9750CM26A
• Device Lot Number: 63675158
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention