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

Model Number 9600TFX20J

Device Problems Particulates (1451); Material Deformation (2976)

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

Event Date 10/21/2020

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 20mm sapien 3 valve was prepped per manual.No insertion difficulty was experienced while advancing the valve and commander delivery system through the 14fr esheath.When the valve was delivered to the ascending aorta, cine imaging showed one of the valve stents was protruding approximately 5mm in length from the valve skirt.The valve and delivery system were withdrawn.A new 20mm sapien 3 valve and delivery system were prepared and used for the procedure.No injuries or consequences to the patient were reported.The sapien 3 valve and delivery system were returned to edwards lifesciences for evaluation.During pre-decontamination evaluation, a blue material was observed on the outflow of the crimped valve frame.

Manufacturer Narrative

Additional information: section h6: evaluation codes; section h10: narrative text.The 20mm sapien 3 valve was returned to edwards lifesciences for evaluation.Visual inspection revealed multiple struts bent inward/distorted on the outflow side.Post expansion of the valve, the frame was observed to be distorted/canted.The bent struts at the inflow side were corrected.One bent strut was observed under the pvl skirt.All leaflets were wrinkled and dehydrated due to storage condition (prolonged crimping) during the device return.One piece of blue material was observed on the outflow of the valve frame.Minor gouges were observed on the delivery system flex tip.Review of the provided device photographs revealed one strut appeared to be bent outward at the inflow side.The ftir analysis on the blue material is currently in process.The color of blue material was identical to the hemostasis valve within the sheath hub.It was speculated that this was the source of the material, but this will be confirmed with ftir analysis.The information from the ftir analysis will be submitted when available.Due to the nature of the complaint, no functional or dimensional testing was able to be performed.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 complaints.Complaint history review from november 2019 to october 2020 for the edwards sapien 3 valve (all models and sizes) revealed other similar reported events for the associated root cause/evaluation codes.Available information suggests that patient/procedural factors (excessive device manipulation, device mishandling) may have contributed to the reported complaint events.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.The lot met the statistical acceptance criteria as the calculated lower tolerance limit (ltl) and/or upper tolerance limit (utl) of each testing fall within the respective lower specification limit (lsl) and/or upper specification limit (usl).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 complaints were confirmed based on the condition of the returned device.A review of dhr, lot history, complaint history, and manufacturing mitigations did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.As reported, ¿when the valve was delivery to the ascending aorta, cine imaging showed one of the valve stents was protruding approximately 5 mm in length from valve skirt¿.Per returned device evaluation, there are bent struts at the inflow side and outflow side.During manufacturing process, all sapien 3 valves are 100% visually inspected for particulate.Therefore, it is highly unlikely that a manufacturing defect contributed to the reported event.· the bent struts at the outflow side was likely due to improper remove the delivery system (with crimped valve) through sheath.Per device returned condition, the delivery system (with crimped valve) was returned without the sheath.Additionally, a blue piece of material was observed at outflow side.In this case, the delivery system (with crimped valve) was removed through the sheath, and the crimped valve was caught on the hemostasis valve within sheath hub.If excessive force was applied to remove the delivery system, it could lead to frame damaged at the outflow side.Per training manual, ¿withdraw the delivery system and sheath as a single unit completely from the arteriotomy¿.· the bent strut at the inflow side was likely due to excessive device maneuvering during delivery system advancement through sheath or anatomy.Per device returned condition (figure 8), gouges on the delivery system flex tip were observed, it indicated excessive device maneuvering during delivery system advancement, which could be potentially from multiple factors (i.E.Non-coaxial insertion through sheath, steep insertion angle, patient¿s anatomy condition, etc.).Although a definite root cause cannot be confirmed, available information suggests that procedural factors (improper removed crimped valve through sheath/excessive device maneuvering) may have contributed to the complaint events.Since no manufacturing defects or labeling/ifu/training deficiencies were identified, neither corrective or preventative actions, nor product risk assessment is required at this time.

Manufacturer Narrative

Additional information: section h10: narrative text.The 20mm sapien 3 valve was returned to edwards lifesciences for evaluation.During visual inspection of the returned valve, one piece of blue material was observed on the outflow of the valve frame.An ftir analysis on the blue particle and a reference hemostasis valve material was performed.Ftir results for the blue particulate and the reference sample from hemostasis valve material were consistent with natural rubber latex, and the correlation between the two sample was 0.9322, indicating that both samples were of the same material.Hence, the blue particulate observed on the valve was identical to the hemostasis valve within the sheath hub.Since the sheath was not returned, the further evaluation on sheath could not be conducted.Complaint history review from november 2019 to october 2020 for the edwards sapien 3 valve (all models and sizes) revealed other similar complaints for particulate/contamination.No manufacturing non-conformances were identified during the evaluations.Definite root causes could not be determined; however, none of these potential root causes are applicable to the current evaluation.In this case, the complaints were confirmed based on the condition of the returned device.A review of dhr, lot history, complaint history, and manufacturing mitigations did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.During manufacturing process, all sapien 3 valves are 100% visually inspected for particulate.Therefore, it is highly unlikely that a manufacturing defect contributed to the event.Per device returned condition, the delivery system (with crimped valve) was returned without the sheath.Additionally, a blue piece of material was observed at outflow side with distorted struts.Per the ftir results, the blue material was identical to the hemostasis valves within the sheath hub.In this case, the crimped valve was potentially caught on the hemostasis valve within sheath hub during the delivery system removal.So, if excessive force was applied, the valve strut could tear off the material from hemostasis valve and resulted in blue particulate as observed.Per training manual, ¿withdraw the delivery system and sheath as a single unit completely from the arteriotomy¿.Although a definite root cause was not able to be determined, available information suggests that procedural factors (improper removed crimped valve through sheath/excessive device manipulation) may have contributed to the particulate material observed on the valve.A definitive root cause was unable to be determined; however, available information suggests that procedural factors (improper removed crimped valve through sheath/excessive device manipulation) may have contributed to the complaint event.Since no manufacturing defects or labeling/ifu/training deficiencies were identified, neither corrective or preventative actions, nor product risk assessment is required at this time.

• Brand Name: EDWARDS SAPIEN 3 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: 11103351
• MDR Text Key: 228174224
• Report Number: 2015691-2020-15341
• 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,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2021
• Device Model Number: 9600TFX20J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/15/2021; 02/09/2021
• Supplement Dates FDA Received: 01/19/2021; 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1