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

Model Number 9600LDS29A

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

Patient Problems Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)

Event Date 02/13/2023

Event Type  Death  

Event Description

As reported by a field clinical specialist (fcs), during the procedure of a 29 mm sapien 3 valve in the aortic valve via transfemoral approach.The patient's vessel was dilated and shock wave prior to delivery system insertion.The operator was unable to get the delivery system and valve past common iliac due to calcified femoral.When the operator was pushing, it was noted that the patient's pressure was "getting soft".The operator tried to pull the delivery system into the sheath; however the delivery system would not go or advance.It was decided to deliver the 29 mm valve into the common iliac.The patient continued to have "soft pressures".The patient was opened and a dissection at the bifurcation up the descending aorta.The patient expired.

Manufacturer Narrative

The investigation is ongoing.The device is not returning.

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 investigation conclusions and investigation findings.Added new information to h.6 type of investigation.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 complaints were unable to be confirmed due to unavailability of returned product/applicable imagery.As no device was returned for evaluation, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined during the evaluation.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.In this case, ''the patient's vessel was dilated and shock wave prior to delivery system insertion.The operator was unable to get the delivery system and valve past common iliac due to calcified femoral.When the operator was pushing, it was noted that the patient's pressure was ''getting soft''.The operator tried to pull the delivery system into the sheath; however the delivery system would not go or advance.It was decided to deliver the 29 mm valve into the common iliac.'' unable to track system through anatomy.The patient's access vessel was calcified, necessitating dilation prior to delivery system insertion, which indicates that the inner vessel diameter would have been appreciably restricted/obstructed.Obstructive calcification can impede the advancement of delivery system via unfavorable interactions between the thv and calcium deposits (e.G., valve frame can lock into calcium).This likely accounts for the reported inability to advance the system beyond the femoral artery, which could have ultimately led to vessel dissection (via high push forces acting on the calcified vasculature by the ds/thv).Difficulty or inability to withdraw system with valve through sheath.The presence of calcification can reduce the vessel lumen diameter and promote sub-optimal withdrawal angles.Therefore, it is possible that the patient's calcified vessel contributed to non-coaxial alignment between the delivery system and the sheath tip, resulting in the reported inability to retrieve the delivery system into sheath.As such, available information suggests that patient factors (calcification) and/or procedural factors (high insertion force) may have contributed to the reported events.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: 16478814
• MDR Text Key: 310614065
• Report Number: 2015691-2023-11213
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)241221(10)64785206
• 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: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS29A
• Device Catalogue Number: 9600LDS29A
• Device Lot Number: 64785206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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): Death
• Patient Sex: Male