MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29A

Device Problems Difficult to Remove (1528); Material Rupture (1546); Failure to Align (2522); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.This is 3 of 3 reports being submitted for this complaint.Reference mfg.Report numbers: 2015691-2020-12320 and 2015691-2020-10321.

Event Description

As per imaging review of the provided cine, a bent valve strut was observed.During a transfemoral procedure with a 29mm commander delivery system, valve alignment in the straight section of the aorta was attempted but the valve could not be aligned in the aorta.Troubleshooting was performed by adjusting the fine adjust wheel, moving up and adjusting approximately 4mm from the distal tip of the marker.The delivery system was not pulled past the warning marker.There was tension in the system.It was discussed that the balloon may not be intact.An attempt was made to withdrawal the system, but difficulty was encountered.A decision was made to deploy the valve in the thoracic aorta.The balloon was unlocked and inflated with nominal volume.The atrion syringe filled with blood and it appeared that the balloon had ruptured.A decision was made to continue to withdrawal the system as unit.Difficulty was noted withdrawing the delivery system/valve through the 16fr sheath as the system was getting caught on the sheath tip.The sheath and delivery system could not be removed through the groin and the aorta was opened to remove the system.The patient is stable.The valve was not deployed.The patient¿s aorta was moderate to severely calcified and tortuous at the bend of the groin.The patient had sufficient "large" iliac arteries.There was no crossing difficulty.

Manufacturer Narrative

The sapien 3 29mm valve was returned with the delivery system to edwards for evaluation.Visual inspection revealed the following: four (4) struts were slightly bent outward at the outflow, all the struts exposed through the skirt (normal after crimped and used), crimped valve had oval shape profile from inflow, and gouges on flex tip.Visual inspection of the post-expanded valve revealed that the frame was distorted/canted, no bent struts were observed as they were self-corrected in position after being fully expanded, all the struts remained exposed through the skirt (normal after crimped and used), and the leaflets appeared wrinkled dehydrated due to storage condition (prolonged crimping during the return handling process.Imaging was provided and revealed multiple struts appeared slightly flared out at the outflow, patient had tortuous and calcified anatomy, the crimped valve appeared diving due to non-coaxial valve alignment, and one (1) strut was slightly bend outward at the outflow.Functional and dimensional testing was unable to be performed due to the condition of the returned device (frame distorted/canted).During incoming inspection of the components, the valve frames are 100% visually and dimensionally inspected by both manufacturing and quality defects per procedure.After cleaning and drying cycle, per procedure, the valve frames are 100% visually inspected.During the final assembly, the sapien 3 valves are 100% visually inspected for defects during manufacturing per procedure before/after holder attachment.Prior to final packaging, 100% visual inspection of the valves are performed at preliminary packaging per procedure to ensure there was no damage to the valves from the handling.These inspections during the manufacturing process support that it is unlikely that a nonconformance contributed to the reported complaint.A device history record (dhr) review was performed and did not reveal any manufacturing related issues that would have contributed to the reported event.A review of the complaint history from july 2019 to june 2020 revealed other similar returned complaints for the trend category above were confirmed.However, no manufacturing non-conformances were identified during the investigations of the similar complaints.Available information suggests that procedural/patient factors may have contributed to the event.The ifu, the device preparation training manual, and the procedural training manual were reviewed for instructions or guidance for proper preparation and use of the devices.The procedural training manual provides guidance on valve alignment.Do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure, rotate the balloon lock away from you to lock and towards you to unlock, lock/unlock symbols are found on the balloon lock, and check delivery system before valve alignment.If kinked, do not use.Manage guidewire position, guidewire can move proximally during valve alignment, the warning marker indicates the balloon catheter is approaching a hard stop.Do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure.Do not position the thv past the distal valve alignment marker.This will prevent proper thv deployment.Additional considerations, compression may be observed in the distal portion of the flex catheter during valve alignment, and diving may be observed between the thv and the flex catheter tip during valve alignment.To correct, move to a different straight section of the aorta (for diving only), if using the balloon catheter, push forward slightly, and then continue pulling back until part of warning marker is visible and if using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.If valve alignment is not performed in a straight section, there may be difficulties performing this step which may lead to delivery system damage and inability to inflate the balloon.Utilizing alternate fluoroscopic views may help with assessing curvature of the anatomy.If excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the aorta and relieving compression (or tension) in the system will be necessary.In addition, the manual provides guidance on thv retrieval back into the sheath tip.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 retrieve, note do not force the thv into the sheath.If resistance is felt, the thv may be caught on the sheath tip., stop, advance thv past the sheath tip and ensure thv is centered on the flex tip.Rotate the delivery system before trying again and note that the crimped thv aligned on the balloon is larger than crimped thv off balloon.Take care if deciding to retrieve.No ifu/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 was confirmed based on the visual inspection of the returned device and review of provided imagery.No manufacturing non-conformances were identified during evaluation.A review of the dhr, lot history, complaint history and manufacturing mitigations revealed no indications that a manufacturing non-conformance contributed to the complaint.Additionally, a review of the ifu and training manual revealed no deficiencies.Per imagery review, the crimped valve appeared diving over the flex tip during the valve alignment.It was likely due to the high tension of valve alignment within a tortuous aorta.The tension can be evidenced by the severe gouges seen on flex tip.Under the high tension and diving condition, the crimped valve could have been flared out (outflow side) and led to enlarged profile.Furthermore, as reported that ¿difficulty was noted withdrawing the delivery system/valve through the 16fr sheath as the system was getting caught on the sheath tip.¿ since patient had tortuous anatomy, the crimped valve could be caught to the sheath tip due to non-coaxial crimped valve retrieval through the sheath.So, if excessive force was applied, it could cause further damage to the valve.In this case, available information suggests that patient factors (tortuosity anatomy) and/or procedural factors (non-coaxial valve alignment/excessive device manipulation during withdrawal) may have contributed to the complaint event.No edwards defect (design/manufacturing/labeling issue) was identified during the investigation.Therefore, no corrective or preventative action, nor product risk assessment is required at this time.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10203753
• MDR Text Key: 197333923
• Report Number: 2015691-2020-12322
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2020

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: 02/01/2022
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 08/26/2020; 07/23/2020
• Supplement Dates FDA Received: 09/01/2020; 11/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR