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

Model Number 9750TFX26

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/22/2020

Event Type  malfunction  

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.

Event Description

As reported by our affiliate in (b)(6), during a transfemoral tavr procedure, a 26mm sapien 3 ultra valve was prepped according to the guidelines.During advancement through the 14fr esheath, the valve got stuck in the partially expandable area of the sheath and it was not possible to proceed.When trying to retract the valve, it got stuck in the hemostasis valves.The sheath, delivery system and valve had to be retracted as a whole.A new sheath, delivery system and sapien 3 ultra valve were prepared and successfully implanted.No injury to the patient was reported.At the time of the report, the patient was in stable condition.The second valve remains implanted in the patient.The initial esheath, valve and delivery system were returned to edwards lifesciences for evaluation, during the pre-decontamination evaluation, 2 struts were observed to be bent when the valve was removed from esheath.Damage to the esheath strain relief was also observed.

Manufacturer Narrative

The sapien 3 ultra valve was returned to edwards lifesciences for evaluation.The valve was returned inside the sheath hub of a 14fr esheath.Visual inspection of the valve revealed 2 struts bent outward at the inflow.All struts were exposed through the skirt, which is normal after crimping and use.No abnormalities were observed at the outflow.Two (2) punctures were observed on the sheath strain relief, aligning with the 2 bent struts.No dimensional analysis or functional testing could be performed due to the condition of the returned device.Device history review (dhr) was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Lot history review revealed no other similar events based on the complaint codes.Although the complaint was confirmed, a complaint history review is not required as the issue has been previously identified in a product risk assessment (pra), which captures root cause analysis for the issue.The instructions for use (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.Push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcium.Do not force sheath.Regarding delivery system insertion through sheath: orient the delivery system with the flush port pointing away and the edwards logo facing up, ensure delivery system is locked in default position.Insertion force through the partially expandable portion can be higher than the push force through the fully expandable portion.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 while advancing the thv/delivery system 1-2 cm.In expectation of high friction, use short movements.If working length is insufficient, peel away the loader tube and remove while maintaining delivery system and wire position.During the manufacturing process, during incoming inspection, the valve frames undergo 100% visual and dimensional inspections by manufacturing and quality.Following the cleaning and drying cycle, the valve frames undergo 100% visual inspection under a minimum 10x magnification.During manufacturing, all sapien 3 ultra valve assemblies undergo multiple 100% visual inspections.During final assembly, the valve undergoes 100% visual inspection before and after holder attachment.These inspections during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.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.In this case, the complaint was confirmed based on the evaluation of the returned valve.No potential manufacturing non-conformance were identified.A review of the dhr, lot history, and manufacturing mitigations did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.As reported, 'all was prepped according to the guidelines but valve got stuck in the partially expandable area of the sheath during insertion and it was not possible to proceed'.Per visual observation of returned product, valve had two struts on inflow bent out, which were aligned with the punctures found on sheath.Per procedure training manual, 'push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification.' these patient or procedural factors alone or in combination can increase resistance and require a high push force for delivery system advancement.If excess force was applied to overcome resistance during the delivery system advancement, valve struts can catch within the sheath and result in damage to valve frame.These patient/procedural conditions, in conjunction with the exposed apices of the crimped sapien 3 ultra thv, may increase the rate of frame damage.A capa has identified potential areas for sapien 3 ultra design/process improvement to mitigate against the failure.Although the exact root cause was not able to be determined, available information suggests that procedural factors (high push force/excessive device manipulation) may have contributed to the complaint event.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation (pra) is not required.However, per management discretion, a capa and pra were previously initiated to assess risks associated with high push force of the commander delivery system with a sapien 3 ultra through the esheath.The risk management worksheet documents the potential for thv exerts force on annulus, resulting in annular rupture, which did not occur during this event.Trending analysis indicates the monthly complaint occurrence rate did not exceed the january 2021 control limit for the appropriate trend category for the sapien 3 ultra valve.

• 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
• MDR Report Key: 11289995
• MDR Text Key: 232167080
• Report Number: 2015691-2021-00255
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2022
• Device Model Number: 9750TFX26
• Device Catalogue Number: 9750TFX26A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1