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

Model Number 9750CM26A

Device Problems Inflation Problem (1310); Failure to Align (2522); Difficult to Advance (2920)

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

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by a field clinical specialist (fcs), during the procedure of a 26 mm sapien 3 ultra resilia valve in the aortic position via transfemoral approach.Lots of torque in the delivery system were noted, and there was difficult to inflate and deflate the valve.The pacing run was a bit longer than usual, however the patient was stable the entire time and was in stable condition after valve deployment.

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 code and investigation conclusions and investigation findings.Added new information to h.6 type of investigation.H.6 investigation findings: blockage identified 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 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 complaint was unable to be confirmed as no device and procedural imagery were provided for evaluation.As the device was not returned, engineering was unable to perform any visual examination, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, 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 ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.As reported by a field clinical specialist (fcs), during the procedure of a 26 mm sapien 3 ultra resilia valve in the aortic position via transfemoral approach.Lots of torque in the delivery system were noted, and there was difficult to inflate and deflate the valve.The pacing run was a bit longer than usual, however the patient was stable the entire time and was in stable condition after valve deployment.Additional information received states that the approximate time of inflation/deflation was ''about 35 seconds to inflate and 35 seconds to deflate''.Patient factors such as tortuosity can contribute to the reported event by presenting challenging pathways and constricting the passageway for the delivery system and may contribute to inflation difficulties.It is possible that during manipulation performed to overcome difficulty positioning the valve within the native valve, the delivery system balloon catheter became temporarily kinked/twisted.A kink can obstruct the inflation fluid pathway, potentially leading to the reported slow inflation/deflation times.As no inflation/deflation issues were reported during device preparation or post-implantation on the back table, it is unlikely that a manufacturing nonconformance contributed to the reported complaint event.As such, available information suggests that patient (tortuosity) and procedural factors (temporarily kinking/twisting of delivery system due to excessive manipulation) 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: 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: 18103797
• MDR Text Key: 327754910
• Report Number: 2015691-2023-17361
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)250614(10)65143605
• 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: 12/15/2023

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: 9750CM26A
• Device Lot Number: 65143605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2023
• 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 Sex: Female