MAUDE Adverse Event Report: EDWARDS LIFESCIENCES US SAPIEN 3 ULTRA VALVE, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX23A

Device Problem Material Deformation (2976)

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

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

Per pre-deco findings revealed a sheath puncture resulting in a minor bent strut observed on the inflow side of valve.As reported by the edwards field clinical specialist, during implant of a 23mm sapien 3 ultra valve in the aortic position, the first valve and delivery system was wasted due to the inability to advance through the iliac stent in the working side.During removal of the delivery system with valve, the valve was pulled off the delivery system and got stuck in the sheath.The sheath was removed.A second sheath was advanced into the working side and the iliac stent had to be ballooned to a larger diameter with an 8mm peripheral balloon.The second delivery system with valve was able to be advanced and deployed without complication.The 23mm sapien 3 ultra valve was successfully deployed.

Manufacturer Narrative

Update to h6 (component code, type of investigation, investigation findings, and investigation conclusion), and h10 to reflect device evaluation.The 23mm sapien 3 ultra valve was returned to edwards for evaluation.Visual inspection revealed crimped thv stuck inside the sheath housing, minor bent strut at the inflow and outflow side.After the valve was expanded visual inspection revealed no bent struts, frame distorted/canted, and leaflets were wrinkled and dehydrated due to storage condition (prolonged crimping) during the return handling process.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint event.A lot history review was performed and did not reveal any other complaints related to this event.The commander with s3/s3u/s3ur ifu and procedural training manual commander with s3u was reviewed for instructions and guidance.The procedural training manual provides guidance on delivery system removal.Completely unflex the delivery system, ensure the flex tip is still over the triple marker, ensure balloon lock is locked, ensure the balloon is completely deflated, retract loader (if needed), pull the entire delivery system through the sheath, and maintain guidewire position in the aorta.In addition, patient injury could occur if the delivery system is not completely unflexed prior to removal.No ifu/training 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 frame damage was confirmed based on returned device.A review of the dhr and lot history 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, 'during implant of a 23mm sapien 3 ultra valve in the aortic position, the first valve and delivery system was wasted due to the inability to advance through the iliac stent in the working side.' 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'.Based on the complaint description patient had iliac stent.Pre-existing stent caused vessel to have undersized vessel.The presence of undersized vessel can create challenging pathway during delivery system advancement, leading to resistance.In this case, it is possible difficulty was encountered during delivery system advancement so additional manipulation was applied to overcome the resistance.So, if excessive force is applied to manipulate the device, it can lead to the valve struts interacting the sheath shaft and resulted in the valve stuck inside the housing and strut damage at the inflow.In additional, based on the description 'during removal of the delivery system with valve, the valve was pulled off the delivery system and got stuck in the sheath'.Excessive force during withdrawal may cause strut damage observed at the outflow.In this case, available information suggests that patient factors (undersized vessels) and/or procedural factors (excessive device manipulation, high push force, withdraw of crimped thv) may have contributed to the complaint event.However, a conclusive root cause was unable to be determined.Control limits are managed and assessed through 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.A product risk assessment and capa was previously initiated to investigate the cause and assess the risk associated with insertion of commander delivery system with s3u through the esheath+ resulting in frame damage.

• Brand Name: US SAPIEN 3 ULTRA VALVE, 23MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA
• 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: 16388650
• MDR Text Key: 309888959
• Report Number: 2015691-2023-10870
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)250807
• 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: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX23A
• Device Catalogue Number: 9750TFX23A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2022
• 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 Sex: Female