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

Model Number 9610TF26U

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528); Failure to Align (2522); Material Split, Cut or Torn (4008)

Patient Problem Vascular Dissection (3160)

Event Date 09/19/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.H3 other text : the device was not returned.

Event Description

As reported, it was a case of an implant of a 26mm sapien 3 ultra valve, in aortic position by transaxillary approach.Although valve alignment was attempted in a straight section of the aorta, there were alignment difficulties that started during gross alignment in ascending aorta.This was due to the tension of the system.These difficulties continued during fine alignment but was resolve.The operator was managed to pull the balloon into the valve and cross native aortic valve.During balloon inflation, it was not possible to inflate the balloon and blood was observed in the inflation device.The balloon was ruptured, and the valve implant was not performed.During removal, it was difficult to withdraw the system with the valve through esheath and a surgical cutdown was performed to retrieve the device.There was no damage observed on the esheath after the withdrawal.However, a dissection in the subclavian artery occurred.A new 26mm sapien 3 ultra valve was implanted with good result and no complication.After a successful valve deployment, the surgeon was able to fix the subclavian artery.The patient was stable and sent to icu.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 device codes, investigation conclusions and investigation findings.Added new information to h.6 component code and type of investigation.The device was returned to edwards lifesciences for evaluation and the following was observed.Flex shaft bunched and compressed near flex tip.Balloon torn at i/c bond location.Inflation balloon bunched distally of crimped thv.Flex tip gouges observed.Applicable imagery was not provided for review.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 during device evaluation.However, no manufacturing non-conformance was identified during the evaluation.An existing technical summary written by edwards lifesciences has been documented for root cause analysis on tension build up in the system due to valve alignment difficulty resulting in the reported balloon torn and withdrawal difficulty.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event.In addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional testing that occurs with every manufactured lot).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve deployment.It should be noted that these mitigations are still in place.In this case, it was reported that the patient did not have a tortuous aorta and valve alignment was performed in a straight section of the aorta.In addition, during evaluation of the returned device gross alignment and fine adjust were able to be performed without issue.Therefore, a definite root cause for the valve alignment difficulty is unable to be determined with information available.However, review of available information suggests that procedural factors (high valve alignment forces, valve's interaction with the balloon, excessive manipulation) may have contributed to the balloon torn while procedural factors (withdrawal of torn balloon) contributed to the withdrawal difficulty.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: 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: 17905396
• MDR Text Key: 325303119
• Report Number: 2015691-2023-16669
• Device Sequence Number: 1
• Product Code: NPT
• 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: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF26U
• Device Lot Number: 65097685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• 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 Age: 77 YR
• Patient Sex: Male