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

Model Number 9610TF29

Device Problems Difficult or Delayed Positioning (1157); Appropriate Term/Code Not Available (3191)

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

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported, it was a valve in ring case of an implant of 29mm edwards sapien 3 transcatheter heart valve, in mitral position via transseptal approach.Fluoroscopy video demonstrated 26f non-ew sheath used via right femoral vein (rfv).The patient has an existing ddd ppm insitu.On advancement of the 29mm sapien 3, the valve did not cross the intra atrial septum (ias) completely and therefore the devices were in left ventricle (lv) and left atrium (la) respectively.The delivery system was unsuccessful to be passed through the surgical ring because there was resistance when pushing the valve further.Upon removal, a blue structure was wrapped inside the frame.No issue or any abnormalities were noted during preparation.For suturing/securing the esheath at the insertion site, a silk suture which is darker compared to the blue suture noted.As per medical opinion, the delivery of the system was obstructed by this suture.New devices was prepared.The patient did not have any adverse consequences because of it and was discharged the very next day of the procedure.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: added new information to h.6 component codes, type of investigation, investigation findings and investigation conclusions.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was provided from the site and revealed the following: video of difficulty crossing the septal wall and blue suture material entangled in crimped thv post-removal.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaints were confirmed by evaluation of the returned device.However, a manufacturing non-conformance was unable to be determined.Additionally, a review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.As reported, ''on advancement of the 29mm sapien 3, the stent frame did not cross the intra atrial septum (ias) completely and therefore the nose cone and distal part of delivery system and majority of stent frame was in lv and la respectively.However, the delivery system was unsuccessful to be passed through the surgical ring.'' additionally, ''there was resistance when pushing the stent frame further and when we took out the valve, it seems the stent frame was entangled in a suture.It was then removed and inspected.A blue structure wrapped inside the frame.'' the review of the provide imagery shows the delivery system unable to be advanced through the septal wall.Due to the limited information a definite root cause is unable to be determined at this time, however it is possible patient factors such as tortuosity and calcification contributed to the challenging pathway for the delivery system to advance through.Additionally procedural factors such as improper septal wall opening, interactions with the existing ring and improper guidewire placements may have contributed to the reported event.At this time is not possible to determine the origin of the reported suture with the limited information provided however, it is possible that the blue suture material observed wrapped around the thv was introduced during from the catheter lab environment during the procedure.Multiple sutures are typically used as part of standard catheter lab procedures to secure medical equipment, including securing the sheath into place at the femoral artery incision site, and securing hemostatic clamps in place.It is possible that during the procedure trimmed fragments of these sutures were introduced into the system and became entangled with the crimped thv.A definite root cause is unable to be determined at this time, however patient factors (patient anatomy) and or procedural factors (improper septal wall opening, interaction with pre-existing ring, improper guidewire placements, introduction of suture material from surgical environment) may have contributed to the reported 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 ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: 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: 15237685
• MDR Text Key: 302719137
• Report Number: 2015691-2022-07351
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2023
• Device Model Number: 9610TF29
• Device Lot Number: 63938005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• 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