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

Model Number 9750TFX26

Device Problem Material Twisted/Bent (2981)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-09388.

Event Description

As reported by our edwards affiliate in germany, a 26mm sapien 3 ultra valve was deployed in the aortic position via the transfemoral approach.Resistance was encountered during the advancement of the valve and commander delivery system through the esheath.While pushing the delivery system through the sheath, it was noted that the valve was not inside of the sheath.The first third of the device was outside of the sheath.Surgical removal of the devices was performed.During the vascular surgery, the external iliac artery was also repaired.At the time of the report, the patient was recovering well and has been extubated.No valve was deployed.It was perceived that severe vessel tortuosity and heavy vessel calcification contributed to the event.The initial esheath, sapien 3 ultra valve and commander delivery system were returned to edwards lifesciences for evaluation.Pre-decontamination evaluation of the esheath revealed the liner was torn starting 6mm from the strain relief to the tip.The valve was returned stuck in the sheath.A piece of the vessel was attached to the esheath.Evaluation of the valve revealed 2 struts bent inwards.

Manufacturer Narrative

The 26mm sapien 3 ultra valve was returned to edwards for evaluation.Visual inspection revealed the following: two bent struts inwardly at the outflow and all struts were exposed through the skirt.After the valve was expanded visual inspection revealed that the leaflets were wrinkled and dehydrated due to storage (prolong crimping) during the return handling process, bent strut at outflow was corrected after expansion and the frame was distorted and canted.Functional or dimensional testing was not performed due to the condition of the returned device (frame distorted/canted).A device history records (dhr) review did not reveal any issues that could have contributed to the reported events.A review of lot history revealed did not reveal other similar reported events.During manufacturing all inspections are conducted on 100% of units.During incoming inspection of the components, the valve frames are dimensionally inspected and visually inspected by both manufacturing and quality.Prior to final packaging, 100% visual inspection of the valves were performed at preliminary packaging per procedure to ensure there was no damage to the valves from the handling between holder inspection and brep process.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The sapien 3 and sapien 3 ultra valve with commander delivery system ifu and procedural training manual were reviewed for instructions and guidance.The procedural training manual provides guidance on delivery system insertion through sheath.Correctly orient delivery system and check position before insertion, orient the delivery system with the flush port pointing away and the edwards logo facing up, ensure delivery system is locked in default, if working length is insufficient, peel away the loader tube and remove while maintaining delivery system and wire position.Insertion force through the partially expandable portion can be higher than the push force through the fully expandable portion.In expectation of high friction, use short movements and push delivery system closer to sheath hub.Push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification.Following proper valve crimping technique and ensure valve is delivered as straight as possible.Be careful to not bend the proximal end of the sheath when inserting the delivery system through the sheath.If push force is too high or valve is initially stuck, zoom in and rotate the c-arm to ensure valve and sheath are not damaged and if damaged, retract valve in sheath slightly.Remove valve and sheath together as single unit and replace.If push force is high, consider slightly pulling back the sheath 1-2 cm while advancing the thv/delivery system.If push force is too high or valve is still stuck, remove valve and sheath together as a single unit and replace.Do not over-manipulate the sheath at any time.The thv should not be advanced through the sheath if the sheath tip is not above the renal arteries.No ifu or 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, lot history, complaint history, and manufacturing mitigation 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 the insertion of the commander delivery system with crimped valve through esheath, resistance was felt.Whilst pushing, it was noticed at screen that the valve was not inside the esheath (first third of the insertion).The valve was not deployed, and the patient had a surgical vascular removal of the entire system and the external iliac had to be repaired.The patient was extubated and was recovering well post procedure.As per medical opinion, event was due to patient's femoral vessels tortuosity with many angles and highly calcified'.In this case, the crimped valve was protruded through the sheath liner.During the crimped valve retrieval into the sheath, the crimped valve was likely caught at the liner, and the further device manipulation led to the bent struts at outflow.In this case, available information suggests that procedural factors (retrieved crimped valve, excessive device manipulation) may have contributed to the complaint event.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 was required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA
• 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: 16109371
• MDR Text Key: 306781459
• Report Number: 2015691-2023-09998
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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: 04/03/2024
• Device Model Number: 9750TFX26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• 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