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

Model Number 9600TFX26

Device Problems Fracture (1260); Failure to Advance (2524); Material Deformation (2976)

Patient Problems Scar Tissue (2060); No Consequences Or Impact To Patient (2199); Fibrosis (3167)

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is ongoing.

Event Description

As reported by field clinical specialist (fcs), during a transfemoral tavr case, there was difficulty inserting the delivery system in a patient with a very scarred and fibrotic tissue tract on the right femoral side;  the physician inserted the 14fr dilator followed by the sheath and introducer.It required ¿extremely great force¿ to advance the delivery sheath thru the tissue tract although the vessel diameter was 8 mm plus.When attempts were made to advance the 26 mm sapien 3 valve thru the sheath, the valve and delivery system would not advance thru the tissue tract.Under fluoroscopy, they advanced the valve and could see the distal end of the crimped stent fracture and puncture the sheath.They pulled everything out with no issues.It was then decided to use a 16fr esheath to dilate the tract even more and give the next 26 mm sapien 3 a better chance of advancing through.This was successful and the patient is doing well and has no issues due to the first sheath being punctured in the tissue tract.The vessel was not tortuous or calcified.  the vessel was ¿very good¿.However, the tissue tract was scarred and fibrotic which is what put such stress on the sheath.There were no difficulties crimping the valve.The team did not attempt to withdrawal the delivery system and valve through the sheath, as the field clinical specialist (fcs) asked them not to, asking them to remove the delivery system, valve and sheath at the same time.There was no injury to the patient.The delivery system and valve are still in the sheath, and will be returned to edwards lifesciences for evaluation.

Manufacturer Narrative

A photograph of the device and procedural cine were provided from the site and it was noted that the loader was fully inserted.The valve was returned to edwards lifesciences for evaluation crimped on the inflation balloon, punctured through the esheath.A photograph of the sheath post-procedure was provided revealing that the sheath was punctured at the strain relief.Based on review of the provided cine, the struts of the valve were not bent during the initial insertion.A valve strut bent and perforated the sheath during insertion.Upon further insertion the strut bent backwards.The returned valve was visually inspected for any abnormalities.All leaflets were dehydrated/wrinkled.There was an exposed strut through the seam, at cp1, likely due to device manipulation.The frame was distorted.A strut was bent backward at cp1.The pvl skirt was cut by engineers for further evaluation.The enlarged/stretched holes in the main and pvl skirts were due to the manual removal of the stitches by engineering.Due to the condition of the returned valve (distorted frame, bent strut), no functional or dimensional testing was performed.The complaint was confirmed through visual inspection.The work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint were reviewed.Review of these work orders did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.A lot history review did not reveal any other complaints related to ¿frame¿ damaged-during use¿ for the related work order.Note that lot numbers for valve complaints reference the valve serial number only.Therefore, this review was performed by taking the valve serial numbers from the related work order and verifying that there has been no other complaint associated with each serial number.A review of complaint history for the sapien 3 (all sizes) used with the commander delivery system, from september 2017 to august 2018, revealed other returned complaints for ¿frame ¿ damaged-during use¿.Two complaints were confirmed, but no manufacturing non-conformances that would have contributed to the reported events were identified.Available information suggests that patient factors (interaction with calcification present in aorta) may have contributed to the reported events.One complaint was confirmed, but no manufacturing nonconformances that would have contributed to the reported event were identified.Available information suggests that patient (aorta calcification) and/or procedural (device manipulation to retrieve the valve that was already caught on calcium) factors may have contributed to the complaint event.Five complaints were confirmed, but no manufacturing nonconformances that would have contributed to the reported events were identified.The struts were likely bent either during valve alignment or delivery system insertion.Available information suggests that procedural factors (device manipulation applied to overcome insertion difficulty through sheath or valve alignment difficulty) and/or patient factors may have contributed to the events.One complaint was confirmed, but no manufacturing nonconformances that would have contributed to the reported event were identified.Available information suggests that patient (tortuosity/calcification in the aorta) and/or procedural (device manipulation applied to overcome insertion difficulty through sheath; valve caught on sheath seals during withdrawal) factors may have contributed to the reported event.Five complaints were confirmed, but no manufacturing nonconformances that would have contributed to the reported events were identified.Available information suggests that patient (tortuous anatomy) and/or procedural (valve struts caught on sheath tip during withdrawal) factors may have contributed to the reported events.One complaint was confirmed, but no manufacturing nonconformances that would have contributed to the reported event were identified.Available information suggests that procedural factors (device manipulation applied to overcome insertion difficulty through sheath) may have contributed to the reported event.A review of complaint history reveals that the occurrence rate did not exceed the september 2018 control limit for the ¿valve damaged¿ trend category.The commander delivery system instructions for use (ifu), esheath instructions for use (ifu), device prepping manual, and training manual were reviewed for instructions relating to the complaint event.No ifu/training deficiencies were identified.During manufacturing, the sapien 3 assemblies underwent the multiple 100% inspections.The in-process sapien 3 valves were 100% visually inspected for defects during manufacturing.Frame components were 100% visually inspected by both manufacturing and quality for material loss, protrusions, distortions, poor finish, fractures/cracks, and holes.They were 100% dimensionally inspected, and 100% visually inspected by manufacturing for scratches, grooves, and deformation using 10x magnification after cleaning and drying cycle.Prior to final packaging, 100% visual inspection was performed at preliminary packaging to ensure no damage was done to the valve from handling between holder inspection and the brep process.These manufacturing inspections support that it is unlikely that a manufacturing nonconformance contributed to the reported complaint.The complaint for ¿frame ¿ damaged-during use¿ is confirmed based on the provided relevant cine and visual inspection of the returned device, but no manufacturing/product non-conformances were identified during evaluation.A review of the complaint history, lot history, the dhr, and manufacturing mitigations revealed no indication that a manufacturing non-conformance contributed to the complaint.As reported, during insertion of the valve through the sheath, it ¿would not advance thru the tissue tract¿.Review of the cine revealed that one strut was bent backwards during insertion, likely resulting in the inability to advance the valve.It was also stated that ¿the tissue tract was scarred and fibrotic which is what put such stress on the sheath¿.This stress on the sheath could have made it difficult to expand, resulting in insertion difficulty and the valve strut catching on the sheath.Subsequent device manipulation to overcome the insertion difficulty could have damaged the frame.A definitive root cause is unable to be determined at this time; however, it is possible that patient (scarred/fibrotic tissue tract) and/or procedural (device manipulation as a result of insertion difficulty) factors contributed to the complaint event.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.Since no manufacturing non-conformances or labeling/ifu/training deficiencies were identified, no corrective/ preventative actions are required.Since no product non-conformance was confirmed and the complaint occurrence rate did not exceed the applicable trending control limit, a product risk assessment (pra) escalation is not required.Based on the provided cine and visual inspection of the returned device, the complaint for ¿frame ¿ damaged-during use¿ was confirmed.A definitive root cause is unable to be determined at this time; however, available information suggests that patient (scarred/fibrotic tissue tract) and/or procedural factors (device manipulation as a result of insertion difficulty) contributed to the complaint event.Since no manufacturing/product non-conformances or no labeling or ifu/training inadequacies were identified and review of the complaint history revealed that the occurrence rate did not exceed the august 2018 control limit for the applicable trend category, neither a pra nor corrective or preventative action was required.

Manufacturer Narrative

Reference capa-20-00141.

• 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: 7846730
• MDR Text Key: 119796884
• Report Number: 2015691-2018-03673
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2018

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: 04/26/2020
• Device Model Number: 9600TFX26
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 10/10/2018; 07/23/2020
• Supplement Dates FDA Received: 10/11/2018; 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention