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

Model Number COMMANDER DELIVERY SYSTEM UNKNOWN

Device Problems Difficult or Delayed Positioning (1157); Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.

Event Description

Edwards received notification from a field clinical specialist that during a transeptal tmvr in a preexisting surgical valve, the operator was unable to cross the septum with the commander delivery system and 29mm sapien 3 valve due to anatomical reasons.It was decided to remove the system as a unit in order to re-balloon the septum.Upon removal, the commander delivery system balloon was observed to be torn at the triple markers, which was likely due to the manipulation of the devices.After ballooning the septostomy, a new valve/delivery system and sheath were used and the valve was successfully implanted.There were no patient injuries.The root cause was noted to have stemmed from a bad puncture location at the septum and a lot of manipulation/flexing to be able to successfully cross the septum.If the initial puncture was in the proper location, this would not have occurred.

Manufacturer Narrative

The device was not returned for evaluation.Therefore, a no product return engineering evaluation was performed.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaint of delivery system unable to cross septal wall and delivery system leakage were unable to be confirmed due to the unavailability of the device/applicable imagery.Due to the device not being returned for further evaluation, a potential manufacturing nonconformance was unable to be identified.A review of the ifu and training manuals revealed no deficiencies.As reported, 'the same difficulty occurred while trying to cross the septum and the entire system was removed as a unit to prevent injury to the patient.' difficulty crossing the septal wall can be caused by the following factors: flexing delivery system incorrectly, orienting e-logo incorrectly, patient anatomy not accurately assessed, user torques delivery system, balloon shaft not locked after valve alignment.Per the event, 'the root cause was noted to have stemmed from a bad puncture location.' a definite root cause is unable to be determine at this time however, available information suggests procedural factors (puncture location) contributed to the reported event of the delivery systems inability to properly cross the septal wall.As reported, 'upon removal, the commander delivery system balloon was torn at the triple markers which was likely due to the manipulation of the devices.' although the exact location and nature of damage could not be confirmed, it is possible high forces/excessive manipulation on the system during septum crossing or withdrawal resulted in balloon/delivery system leakage prior to successful withdrawal of delivery system.A definite root cause is unable to be determined.However, available information suggests procedural factors (excessive manipulation) contributed to the reported event.The complaints for delivery system unable to cross septal wall and delivery system leakage was unable to be confirmed.No manufacturing non-conformances were identified during the evaluation.A definite root cause is unable to be determine at this time however, available information suggests procedural factors (puncture location) contributed to the reported event.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action is required at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12272129
• MDR Text Key: 265244081
• Report Number: 2015691-2021-04481
• Device Sequence Number: 1
• Product Code: NPU
• 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: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMMANDER DELIVERY SYSTEM UNKNOWN
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1