MAUDE Adverse Event Report: EDWARDS LIFESCIENCES US SAPIEN 3 ULTRA VALVE (26MM); AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX26A

Device Problems Failure to Advance (2524); Material Deformation (2976); Material Twisted/Bent (2981); Mechanical Jam (2983)

Patient Problems No Known Impact Or Consequence To Patient (2692); Fibrosis (3167)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

Udi number: (b)(4).The investigation is ongoing.

Event Description

26mm sapien 3 ultra valve, 26mm commander ds, esheath during implant of 26mm sapien 3 ultra valve in the aortic position using transfemoral approach, the valve and delivery system got stuck in the esheath and had to be removed and discarded.A 16 fr esheath was then used, however, a second 26mm sapien 3 ultra valve and delivery system also got stuck in the esheath.One of the stent ¿tines¿ was bent outward.Since it would not advance and due to potential for injury from the bent stent, this valve was also removed and discarded.The third 26mm sapien 3 ultra valve was able to be inserted past the fibrotic vessel and implanted without issue for a great result.Per the physician, the patient¿s access vessel was very fibrotic (like leather perhaps), which would not expand and allow the valve to pass through.

Manufacturer Narrative

The devices were not returned to edwards lifesciences for evaluation.No imagery of used device was provided.Therefore, no visual, functional, or dimensional analysis could be performed.The ifu, device preparation training manual, procedural training manual, and procedural manual were reviewed for guidance involving esheath and delivery system usage.The user is instructed to ensure adequate vessel access and not to use the esheath in tortuous or calcified vessels that would prevent safe entry of the sheath.Additional considerations include proper screening as this is critical to reduce vascular complications.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 position.Shorter loader (valve sizes 20, 23 and 26mm): loader does not peel away.Keep loader completely inserted in sheath until just before delivery system removal at end of procedure to maximize system working length.Longer loader (valve sizes 20, 23, 26 and 29mm): if working length is sufficient, peel away the loader tube.Note: maintain edwards logo up throughout the procedure to prevent kinking of the delivery system.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.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.Thv retrieval back into sheath tip: ensure the delivery system is locked.Verify the flex catheter is completely unflexed.Ensure the edwards logo on the sheath handle is facing upward.Withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position.Do not re-use the sheath, thv or delivery system once thv is retrieved.Based on the review of the ifu and training manual, no deficiencies were identified.Dhr review did not reveal any manufacturing related issues that would have contributed to this complaint.A lot history review revealed other similar complaints, but no manufacturing non conformances were identified during the investigation.A complaint history review from may 2019 to april 2020 revealed other similar complaints, but no manufacturing non conformances were identified during the investigation.During manufacturing, the valve frame and components are inspected several times throughout the manufacturing process.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformances contributed to the reported events.Per the report, a second 26mm sapien 3 ultra valve and delivery system also got stuck in the esheath.One of the stent ¿tines¿ was bent outward, the loader was not fully inserted into the sheath, and the vessel could not expand as the valve passed through the sheath due to the access vessel being fibrous/leathery.The fibrous/leathery access vessel may have prevented the sheath from proper expansion, resulting in the valve getting caught within the sheath and lead to resistance during delivery system insertion through the sheath.With excessive device manipulation, the valve struts could be bent.Additionally, as instructed per ifu, the loader should be fully inserted into the sheath before device insertion.The loader is used to facilitate the smooth transition of the crimped valve through the hub of sheath.Without fully inserting the loader into the sheath, the valve struts could be interacted and caught onto the hemostasis valves within the hub, and lead to frame damaged.Although a definitive root cause was unable to be determined at this time, available information suggests that patient factors (fibrous/leathery access vessel) and/or procedural factors (excessive device manipulation/ not fully inserted loader) may have contributed to the complaint event.The complaint for ¿frame ¿ damaged-during use¿ was unable to be confirmed.Due to the unavailability of a returned device (valve) and/or relevant imagery, no potential manufacturing non-conformance was able to be determined.However, a review of the lot history, dhr, manufacturing mitigations and complaint history did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.Additionally, a review of the ifu and training manual revealed no deficiencies.Available information suggests that patient factors (fibrous/leathery access vessel) and/or procedural factors (excessive device manipulation/ not fully inserted loader) may have contributed to the complaint event.No ifu/training manual deficiencies were identified, therefore, no corrective or preventative action, nor risk assessment is required at this time.

Manufacturer Narrative

Per the fcs, the sheath was not fully inserted in to the patient due to the patient¿s height.The hub of the sheath/strain relief was not in the vessel.When the third sheath was used, it was placed all the way in the patient.The delivery system got stuck in the sheath where the vessel meets the sheath, at the stick point.The loader was not fully inserted into the sheath.The delivery system was in default position during insertion.The vessel mld was adequate, but the vessel was fibrous/leathery.The physician felt that the vessel could not expand as the valve passed through the sheath.It was unknown how steep the insertion angle was.The vessel was pre-dilated up to 16fr.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: US SAPIEN 3 ULTRA VALVE (26MM)
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10016347
• MDR Text Key: 195017758
• Report Number: 2015691-2020-11743
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2022
• Device Model Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1