MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX26A

Device Problem Material Deformation (2976)

Patient Problem Perforation of Vessels (2135)

Event Date 12/21/2022

Event Type  Death  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted upon completion.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-10229.

Event Description

Edwards received notification from a field clinical specialist that during a transfemoral tavr, there was resistance between a 26mm sapien 3 ultra valve/delivery system and the 14fr esheath+.Valve frame damage was noted.As reported, the 14fr esheath+ was introduced into the left femoral artery with no difficulty.When the commander delivery system was introduced into the esheath+, the team had difficulty advancing the delivery system in the expandable portion.The team immediately panned the x-ray camera down to the left groin, and at that point it was realized that the distal edge of the s3u valve was protruding into the wall of the esheath+.The team elected to redirect the delivery system in the sheath away from the location of protrusion.Next, the team elected to remove the esheath+ and delivery system as one unit.However, the system would not come out easily.The team then, introduced an aortic occlusion balloon into the aorta via the sheath in the right groin.After the aortic occlusion balloon was introduced into the distal aorta, the team elected to do a cut down procedure on the left common femoral to remove the esheath+ and commander delivery system.Upon removal of the esheath+ and commander delivery system, a section of the common femoral artery avulsed around the sheath.After the esheath+ and delivery system was removed and on the back table, the avulsed section of the artery was visibly still attached to the sheath.With distal flow occluded, the team started to perform an endovascular repair.The patient expired during repair.There was valve frame damage noted.One of the stent struts on the proximal edge of the valve was bent and protruding through the expandable portion of the esheath.

Manufacturer Narrative

The device was not returned for evaluation.Therefore, a no product return engineering evaluation was performed.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 valve frame damage was confirmed based on provided imagery.A review of the dhr, lot history, and manufacturing mitigations did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.As reported, ''when the commander delivery system was introduced into the esheath+, the team had difficulty advancing the delivery system in the expandable portion.The team immediately panned the x-ray camera down to the left groin, and at that point it was realized that the distal edge of the s3u valve was protruding into the wall of the esheath+.One of the stent struts on the proximal edge of the valve was bent and protruding through the expandable portion of the esheath.'' per training manual, ''push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification'', ''if push force is high, consider slightly pulling back the sheath 1-2 cm while advancing the thv/delivery system'', and ''do not over-manipulate the sheath at any time''.Per imagery review, patient's left access vessel had presence of calcification and tortuosity.The presence of calcification and tortuosity can create challenging pathway during delivery system advancement, leading to resistance.In this case, if excessive force was used to overcome the resistance, it could have led to the valve struts interacting with the sheath shaft, resulting in frame damage/bent struts, as seen at inflow.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (excessive device manipulation) may have contributed to the complaint event.However, a definitive root cause is unable to be determined.No labeling or ifu/training inadequacies were identified.A product risk assessment (pra) has previously been initiated to capture the product risk assessment, and capa has been initiated to capture further investigation and corrective/preventive action activities.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.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• 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: 16179610
• MDR Text Key: 307454332
• Report Number: 2015691-2023-10230
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)250802
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX26A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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): Required Intervention; Death
• Patient Sex: Male