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

Model Number 9610TF26

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 01/26/2023

Event Type  Injury  

Event Description

As reported from our affiliates in france, this was a case of a 26mm sapien 3 valve in mitral position by transfemoral vein approach within a pre-existing non-edwards surgical valve.After the trans-septal puncture, it was decided to use a 18ml dilation balloon due to the septum thickness.The safari guidewire was positioned into the left ventricle and the commander delivery system with the crimped valve were advanced.No difficulty was reported during the advancement of the delivery system and the alignment of the valve.When pushing the system into the septum, the guidewire was close to the exit of the left ventricle, so the physician retracted the commander delivery system a bit.By doing so, the valve advanced onto the balloon, until it completely came off the commander system but was still on the guidewire.The delivery system was retrieved while the valve was still on the guidewire.The delivery system was strongly manipulated since a lot of tension was experienced during the interatrial septum crossing and trying to pull the valve out of the patient.The sheath was replaced with a non-edwards 24f introducer.A lasso catheter was then introduced, and it was managed to capture the valve with it, pulling the valve back into the right atrium and back to the introducer until it was completely removed out of the patient and discarded.Another valve and commander delivery system were used in replacement.The valve was successfully implanted.The patient did not suffer any consequences and was noted to be fine.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

Updated h6-type of investigation, investigation findings, investigation conclusions.Corrected h6- component code.The device was not returned for evaluation.A cine photo was provided by the complaint event site and the valve was observed dislodged off the inflation balloon.The complaint for valve dislodged off balloon was confirmed based on evaluation of provided imagery.Due to unavailability of the device, engineering was unable to be perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined.A review of the device history record, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu a nd training manuals revealed no deficiencies.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure modes is not required at this time.The complaint description states, "when pushing the system into the septum, the guidewire was close to the exit of the left ventricle, so the physician retracted the commander delivery system a bit.By doing so, the valve advanced onto the balloon, until it totally came of the commander system but was still on the guidewire.The delivery system was retrieved while the valve was still on the guidewire and the sheath was replaced by a non-edwards 24f introducer." as revealed by the provided imagery, the valve was dislodged off the balloon and remained on the guidewire.The case notes revealed tension was observed during the interatrial septum crossing.As reported, "they strongly manipulated the system to try to cross the septum and then to try to pull the valve out of the patient." if the interatrial septum was not adequately dilated for the delivery system to advance through, it may result in the tension crossing the septal wall.It is possible that the valve interacted with the anatomy during crossing and, upon retraction, was manipulated and forced proximally over the balloon and eventually dislodged.A definitive root cause is unable to be determined.However, available information suggests that procedural factors (valve interaction with septal wall, excessive manipulation) may have contributed to the reported complaint event.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.No corrective or preventative actions are required.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: MITRAL VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16421817
• MDR Text Key: 310041979
• Report Number: 2015691-2023-10992
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF26
• Device Catalogue Number: N/A
• Device Lot Number: 64692205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female