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

Model Number 9750TFX26A

Device Problem Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 12/31/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).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, during a transfemoral tavr procedure, resistance was encountered as a 26mm sapien 3 ultra valve and commander delivery system advanced through the a 14fr esheath.It was observed that the valve ¿came through¿ the side of the sheath and was in the adipose tissue.The valve and delivery system were surgically removed.A 16fr esheath, a new valve and a new delivery system were then prepared and used for the procedure.At the time of the report, the patient was in stable condition and has been discarded.At the time of the initial report, the edwards specialist reported no valve damage was apparent.The valve and delivery system were returned to edwards for evaluation.Pre-decontamination evaluation of the valve indicated the frame was damaged and a strut was bent.

Manufacturer Narrative

The sapien 3 ultra valve was returned to edwards lifesciences for evaluation.The valve was returned crimped on a commander delivery system and exposed through the esheath.Visual inspection of the valve revealed multiple bent/distorted struts on the inflow side of the valve.Following expansion of the valve by the engineers, 3 struts between c1 and c3, were bent outward approximately 180 degrees, and 1 strut was bent outward approximately 90 degrees.One (1) strut near c1 was bent slightly inward.The valve frame was noted to be canted/distorted.All leaflets were wrinkled and dehydrated due to the prolonged crimping during the return handling process.Gouges in the delivery system flex tip were reported.Review of the provided 3mensio report which includes screening images of the patient's anatomy revealed the presence of tortuosity in the right access vessel.Review of the fluoroscopy image revealed multiple bent struts on the inflow of the valve, and the valve protruding through the sheath.No dimensional analysis or functional testing was able to 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 related complaints.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), 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 imagery review and evaluation of the returned valve.A review of the dhr, and lot history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of manufacturing mitigations supports that proper inspections are in place to detect issues relating to the complaint.Per complaint description, 'resistance was encountered as a 26mm sapien 3 ultra valve and commander delivery system advanced through the 14fr esheath.It was observed that the valve 'came through' the side of the sheath and was in the adipose tissue' and 'pre-decontamination evaluation of the valve indicated the frame was damaged and a strut was bent'.Per procedure training manual, 'push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification.' as seen in 3mensio report patient's access vessel (right) was tortuous.Additionally, per the case notes, the sheath was inserted at a [?]45 degrees angle.The presence of tortuosity access vessel and steep insertion angles can create a challenging pathway as it can create sub-optimal angles for delivery system (crimped valve) insertion through sheath.This may lead to non-coaxial delivery system insertion, which would result in increased resistance for delivery system/thv advancement.During product evaluation, gouges on flex tip was observed which is also an indicative of excess device manipulation.So, if the excess force was applied to overcome resistance during the delivery system advancement, it can lead to valve struts 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.Although a definite root cause was not able to be determined, available information suggests in addition to procedural factors (damaged valve / bent struts caught on sheath / excessive device manipulation during device insertion and retrieval), patient factors (vessel tortuosity) may have contributed to the femoral artery dissection and subsequent surgical vascular repair.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.However, per management discretion, a pra was previously initiated to assess the risks associated with valve frame damage due to high push force of the commander delivery system with s3u through the esheath.In addition, a capa has been initiated to capture further investigation and corrective/preventive action activities.Trending analysis indicates the monthly complaint occurrence rate did not exceed january 2021 control limit for trend appropriate category for the sapien 3 ultra valve (s3u).This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2021-00253.

• 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: 11228956
• MDR Text Key: 228633636
• Report Number: 2015691-2021-00238
• 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
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2022
• Device Model Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1