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

Model Number 9610TF23U

Device Problem Positioning Failure (1158)

Patient Problem Rupture (2208)

Event Date 08/31/2022

Event Type  Death  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by an edwards (b)(6) affiliate, during a transfemoral tavr procedure with a sapien 3 ultra valve, there was resistance during insertion of the delivery system while advancing up the descending aorta and across the annulus.The team struggle to advance upon flex into the aortic arch and the position did not look right.They system was mid aortic arch, and started to back up upon push.It was decided to removed a little flex and continue to pushed on (no more than usual resistance confirmed).The patient developed severe discomfort at this point, and the operator tried to advance the system further.However, the system jumped.Per report, it is believed that the device caught on calcium at this point resulting in an rupture.Resuscitation was attempted, but the patient passed away.

Manufacturer Narrative

Correction to h6 based on additional information.The device was not returned to edwards lifesciences for evaluation, however, a device history record (dhr) review was done, and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.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 complaint for unable to track system through anatomy was unable to be confirmed due to unavailability of the complaint device and/or applicable imagery.As the device was not returned for evaluation, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance could not be determined.As reported, 'upon advancing the commander system, it seemed to struggle to advance upon flex into the aortic arch and position did not look right.System only got to mid aortic arch and started to back up on itself upon push.Lead consultant then removed a little flex and pushed on (confirmed did not feel a lot of resistance, no more than usual).Patient started to have severe discomfort in the back at this point.Doctor tried to advance the system on.System, then, jumped and it is now believed the calcium it caught on came with system at this point resulting in a rupture.' presence of calcification in the aorta can cause interaction between the advancing delivery system with thv and calcified nodules present, contributing to the reported tracking difficulty and possibly damaging the surround tissue and resulting in the reported aortic rupture.However, definitive root cause was unable to be determined at this time.Available information suggests patient (calcification) and/or procedural factors (excessive manipulation) contributed to the reported event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvne 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: 15506425
• MDR Text Key: 300861187
• Report Number: 2015691-2022-08151
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2024
• Device Model Number: 9610TF23U
• Device Lot Number: 64367920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• 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
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female