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

Model Number 9750CM26A

Device Problem Failure to Advance (2524)

Patient Problem Rupture (2208)

Event Date 02/10/2022

Event Type  Death  

Manufacturer Narrative

Investigation is ongoing.Delivery system was discarded.

Event Description

As reported, 26mm ultra sapien 3 in aortic position via transfemoral approach.The patient's thoracic aorta was extremely tortuous.During valve delivery, the system became difficult to advance to the aortic valve.Due to the tortuosity, energy was building in the thoracic bend.During the attempt of advancing the delivery system to the aortic valve, it appeared that the system moved (jumped or snapped) followed by immediate loss of blood pressure and there was report of major bleeding.It appeared to the team that the descending aorta tore eventually leading to the expiration of the patient.The managing doctor team did not communicate any concerns with the performance of the sheath / delivery system, but rather the extreme tortuosity of patient.

Manufacturer Narrative

As the device was not returned a visual inspection, functional testing, and dimensional testing was not performed.3mensio imagery was returned and evaluated and shows tortuosity on thoracic aorta.A device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to the complaint codes below.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.Edwards has provided the guidelines or instructions to physicians in the ifu and training materials.A review of applicable content revealed that the labeling/ifu/training materials adequately provide warnings and instructions for use and contains the correct content regarding the reported complaint event.A review of the ifu and training material revealed no deficiencies.As the complaints were unable to be confirmed, a complaint history review is not required.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.The complaint for navigate and position catheter to target location unable to track system through anatomy was unable to be confirmed due to unavailability of returned device and / or applicable imagery.Due to unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined.A review of 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.As reported, the patient's thoracic aorta was extremely tortuous.During valve delivery, the system became difficult to advance to the aortic valve.Due to the tortuosity, energy was building in the thoracic bend.Additionally, per returned imagery, tortuosity was present in the thoracic aorta.Tortuous patient anatomy can create sub-optimal angles that can lead to non-axial alignment in the advancement of the delivery system.Available information suggests patient factors (tortuosity) contributed to the reported event.However, due to lack of device return and video imagery of procedural event, a definitive root cause is unable to be determined.Since no product non-conformance was confirmed, a product risk assessment escalation is not required.Since no edwards defect was identified to have contributed to the complaint events, no corrective/preventative actions are required.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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 corrective or preventative actions are required.In this case, there was no allegation or indication a device malfunction contributed to this adverse event of descending aortic rupture.Investigation results suggest/indicate the cause of the aortic rupture is unknown.However procedural factors (device manipulation with difficulty to track system through anatomy) and/or patient factors (tortuosity in the aorta) may have contributed to the event.

• 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: 13667450
• MDR Text Key: 286588177
• Report Number: 2015691-2022-04250
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)231115(10)64096744
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

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: 11/15/2023
• Device Model Number: 9750CM26A
• Device Lot Number: 64096744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/04/2022
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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 Age: 89 YR
• Patient Sex: Male