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

Model Number 9610TF29

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The returned device was visually examined and the following was observed: balloon with crimped valve stuck in the esheath strain relief.Balloon with crimped valve was released from strain relief.No visual damage observed on crimped valve.The guidewire lumen was cracked/broken at crimping balloon area.Leakage was found through nose tip when inflated the balloon, normal due to the broken guidewire lumen observed.No visible damage observed on the balloon nor nose tip.Prior to removing from the return packaging, the distal end of the balloon was observed to be kinked proximal to sheath.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 system component damaged and delivery system leakage was confirmed based on evaluation of the returned device.A review of the complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A review of the ifu and training manuals revealed no deficiencies.As reported ''during procedure, when advancing the commander delivery system and valve through esheath, it was not possible to advance and, the commander and valve got stuck at the beginning of the expandable part of the esheath.The entire system was retrieved as one unit.A second 29mm sapien 3 kit was opened.At this time, the 29mm sapien 3 valve was implanted without complications.The patient did not suffer any injury during procedure.'' for the complaint of system component damaged, during product evaluation of the returned delivery system, guidewire lumen was found broken.As per customer follow up received, ''the specialist indicates that he felt too much resistance when advancing the commander system, when applying more pressure he heard an unusual noise and that is when he observed the valve getting stuck''.The high push force applied to overcame the resistance felt during delivery system advancement could cause the broken guidewire lumen observed during evaluation of returned device.As the delivery system was received partially withdrawn, it is possible that excessive manipulation after retrieving the devices or on the back table may have occurred.If the manipulation is great enough, it is may have resulted in the guidewire lumen breaking within the crimp balloon.As the delivery system was received (within the return packaging) kinked at the section where the damage occurred.It is also possible that manipulations due to return packaging may have created the damaged observed during the evaluation.However, without applicable procedural imagery , a definitive root cause is unable to be determined.Available information suggests that procedural factors (excessive manipulation) may have contributed to the complaint events.For the complaint of delivery system leakage, no damage was reported during delivery system preparing process (de-airing step).During evaluation of the returned device leakage was observed through delivery system nose tip when inflated the balloon.Since the guidewire lumen was broken in crimping balloon area, fluid came out through broken guidewire causing the observed nose tip leakage.Available information suggests that procedural factors (broken guidewire lumen) may have contributed to the complaint events.No manufacturing non-conformance that would have contributed to the complaint events was confirmed during the evaluation.No labeling/ifu deficiencies were identified.Therefore, no further escalation i s required.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.

Event Description

Edwards received notification from our affiliates in colombia.As reported, this was an implant case of a 29mm sapien 3 valve in aortic position by transfemoral approach.During the procedure, when advancing the commander delivery system and valve through esheath, it was not possible to advance.The commander and valve got stuck at the beginning of the expandable part of the esheath.The entire system was retrieved as one unit.A second 29mm sapien 3 kit was opened.At this time, the 29mm sapien 3 valve was implanted without complications.The patient did not experience any injury during procedure.The patient was stable post-procedure.As per the preliminary evaluation of the returned devices, it was found that the guidewire lumen was broken/separated at the crimping balloon area and, there was a leakage observed through the nose tip while inflating the balloon.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, 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: 18539995
• MDR Text Key: 333382536
• Report Number: 2015691-2024-00495
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2022
• 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