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

Model Number 9610TF26U

Device Problems Difficult or Delayed Positioning (1157); Fluid/Blood Leak (1250)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

Edwards received notification from our affiliate in germany.As reported, this was a valve-in-valve case of an implant of a 26mm edwards sapien 3 ultra transcatheter heart valve, in mitral position by transseptal approach, into a non-edwards.During procedure, there were a few problems with the procedure, but it was able to solve them all in the end.The initial problem was that it was not able to pass the septum with the sapien 3 ultra 26mm, even though it was pre-dilated it with a 12mm balloon.As a result, the stiff wire partial embolized to the left atrium.In the end the valve catheter was removed with the prosthesis.Therefore, a new catheter and valve was prepared and implanted successfully.There was no injury to the patient reported.Due to the massive manipulation that had been required the crossing maneuvers attempts, it was noticed that the balloon was damaged with anticipated partial rupture of the balloon and the valve did not look good outside the patient.

Manufacturer Narrative

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

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 complaints of difficulty crossing the septal wall with the delivery system and balloon leak were unable to be confirmed as the device was not returned and no applicable imagery was provided.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu and training manuals revealed no deficiencies.As reported, ''the initial problem was that it was not able to pass the septum with the sapien 3 ultra 26mm, even though it was pre-dilated it with a 12mm balloon.'' per the training manuals, 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, and user torques delivery system, balloon shaft not locked after valve alignment.However, without applicable patient/procedural imaging, a definitive root cause was unable to be determined.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment (pra) is required at this time for the complaint of balloon leak, as reported, ''due to the massive manipulation that had been required the crossing maneuvers attempts, it was noticed that the balloon was damaged with anticipated partial rupture of the balloon''.To overcome the reported difficulty, excessive manipulation was likely required during attempts to cross the septal wall.It is possible that this manipulation caused the balloon to become damaged, resulting in the reported balloon leak.Without applicable patient/procedural imaging, a definitive root cause was unable to be determined.Available information suggests that procedural factors (excessive manipulation) may have contributed to the reported event.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor pra 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 13983168
• MDR Text Key: 297948011
• Report Number: 2015691-2022-04792
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103208078
• UDI-Public: (01)00690103208078(17)230928(10)64009594
• 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: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: 9610TF26U
• Device Catalogue Number: N/A
• Device Lot Number: 64009594
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2021
• 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