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

Model Number 9750TFX23A

Device Problems Material Rupture (1546); Device Slipped (1584); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Scar Tissue (2060); No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The investigation is underway.This is one of two manufacturer reports being submitted for this case.

Event Description

As reported by a field clinical specialist, during the procedure of a 23 mm s3 ultra valve in the aortic position via transfemoral approach the vessels were pre-dilated.The delivery system orientation appeared normal.As the delivery system was inserted, only the nose cone actually entered the cfa.The valve appeared to get caught on the outside of the vessel, due to significant scar tissue from a patient¿s prior arteriotomy.As forward tension was applied to the delivery system, the esheath appears to have ¿ruptured¿ along the seam, exposing the valve and delivery system to the surrounding tissue.No injury to the vessel was reported.The delivery system went forward but the nose cone flipped backwards.The resistance caused a liner tear.There was no steep angle.While attempting to remove the valve, delivery system and esheath as one unit; the valve slipped off of the delivery system and remained in the body.The valve remained in the tissue near the femoral head vascular access site.The esheath and ds were removed together as a unit.A small portion of the valve outflow was exposed externally.A small incision was made and the valve was removed using a hemostat.Another 23 mm s3 valve was prepped and implanted.Upon removal of the valve, frame damage was observed.One of the struts on the inflow was angled 90 degrees from its original position.The damage to the valve frame occurred while still in the patient prior to removal.Per medical opinion.The physician believes the initial resistance was due to significant scar tissue patient factors.Patient is doing well.The patient was noted to have significant calcium and tortuosity.

Manufacturer Narrative

Please reference related manufacturer report no: 2015691-2020-12453.The product was not returned for evaluation.Review of procedural imagery provided by the site showed the patient had calcified anatomy and undersize access vessel mld (minimum luminal diameter).The patient had tortuous access vessels.One (1) strut was bent outward approximately 90 degrees at outflow side, and the multiple struts flared out or distorted at outflow.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the reported complaint.A review of the lot history revealed no other similar complaints.A review of the complaint history found similar complaints.A review of complaint history for the month of june 2020 revealed that the occurrence rate did not exceed the control limit for the valve damaged trend category.The instructions for use (ifu), device preparation and the training manual were reviewed for instructions or guidance for proper use of the edwards sapien 3 ultra and no deficiencies were identified.It is to be noted 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.During the manufacturing process, the sapien 3 ultra is visually inspected by both manufacturing and quality for scratches, fractures/cracks, and any potential defects.The valves are 100% dimensionally inspected.Prior to final packaging, 100% visual inspection of the valves were performed.These inspections during the manufacturing process support that it is unlikely that a nonconformance contributed to the reported complaint.A review of edwards lifesciences risk management documentation was performed for this case.No evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint for frame damaged during use was confirmed based on the provided imagery.Due to the unavailability of a returned device (valve), no potential manufacturing non-conformance was able to be determined.However, a review of lot history, complaint history, dhr and manufacturing mitigations 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.As reported, ¿the valve appeared to get caught on the outside of the vessel, due to significant scar tissue from a patient¿s prior arteriotomy.¿ per medical opinion.The physician believes the initial resistance was due to significant scar tissue patient factors¿ and ¿the patient was noted to have significant calcium and tortuosity.¿ per imagery review, patient had calcified anatomy, tortuous access vessels and undersize access vessel mld (minimum luminal diameter).The presence of calcification, tortuosity and undersize mld of access vessels and significant scar tissue from prior arteriotomy, which could create a challenging pathway for delivery system insertion through the sheath and lead to resistance and high push force.Additional imagery review, the valve strut was bent/distorted at outflow side, it was likely due to the crimped valve caught on the sheath body or patient anatomy when it was trying to reenter back through the tear in sheath liner.If excessive force was applied, it could lead to the observed damage seen on the valve frame at the outflow side.As such, available information suggests that patient factors (access vessel tortuosity, calcification, undersize mld and scar tissue from prior arteriotomy) and/or procedural factors (excessive device maneuvering during retrieval crimped valve through sheath) may have contributed to the complaint event.The complaints were unable to be confirmed.Due to the unavailability of the device it cannot be determined if a manufacturing nonconformance has contributed to the reported events.A product risk assessment was previously opened for potential risks associated with valve frame damaged during use with the sapien 3 ultra.The associated issue did not exceed the(b)(6)2020 complaint trending control limits, and no labeling or ifu/training inadequacies were identified.No corrective or preventative actions are required.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE (THV)
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10251982
• MDR Text Key: 199259119
• Report Number: 2015691-2020-12451
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: 9750TFX23A
• 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
• Patient Age: 79 YR