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

Model Number 9600TFX29

Device Problems Break (1069); Failure to Align (2522); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by (b)(6) affiliate, during implant of a 29mm sapien 3 valve, in the aortic position, by transfemoral approach.The valve alignment was not possible done properly due to the anatomy of aorta and the difficulty during the gross and fine adjustment.Frame damage of the valve was noted, and a decision was made to retrieve the valve into esheath and remove it as a single unit.The patient is stable.There was no injury reported.A new valve was implanted without issue.From pictures the sheath liner was delaminated.The device will be returned for evaluation.

Manufacturer Narrative

This report is 2 of 3 being submitted for this complaint.Reference mfg.Report numbers 2015691-2021-02109 and 2015691-2021-01654.The 29mm sapien valve was returned to edwards for evaluation.Visual inspection revealed the following: valve strut punctured through sheath shaft, one (1) strut bent outward approximately 90 degrees at the outflow, frame slightly distorted, and all struts were exposed through skirt (normal after crimping and use).Functional or dimensional testing was not performed due to the condition of the returned device (frame distorted).During manufacturing per procedures, all inspections are conducted on 100% of the units.During the incoming inspection of the components, the valve frames are 100% dimensionally and visually inspected by both manufacturing and quality.In addition, during product verification (pv) testing, samples are tested for tensile strength.The lot met the statistical acceptance criteria.During final assembly, the sapien 3 ultra valves are 100 percent visually inspected before and after holder attachments during manufacturing.Prior to final packaging, 100 percent visual inspection of the valves was performed.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A device history records (dhr) review did not reveal any issues that could have contributed to the reported events.A review of lot history revealed no other complaints for frame damaged during use.The ifu for commander delivery system with s3u, device preparation training manual, and the procedural training manual was reviewed for instructions relating to the complaint.The procedural training manual provides guidance on delivery system insertion through the sheath.Correctly orient delivery system and check position before insertion, orient the delivery system with the flush port pointing away and the edwards logo facing up, ensure the delivery system is locked in the default position, note maintain edwards logo up throughout the procedure to prevent kinking of the delivery system, insertion force through the partially expandable portion can be higher than the push force through the fully expandable portion, and 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 centimeters and in exception of high friction, use short movements.In addition, the procedural training manual provides guidance on thv retrieval back into the sheath tip.Thv can be retrieved through sheath only before thv deployment (still crimped), ensure the thv is centered on the flex tip, ensure the delivery system is locked, verify the flex catheter is completely unflexed, retract the thv and delivery system into the sheath ensuring the thv is completely inside the sheath and just past the sheath tip, ensure the edwards logo on the sheath handle is facing upward and withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position.The sheath should not be reused once the thv or delivery system has been retrieved.Do not force the thv into the sheath.If resistance is felt, the thv maybe caught on the sheath tip, stop, advance thv past the sheath tip and ensure thv is centered on the flex tip, and rotate the delivery system before tyring again.Note that the crimped thv aligned on the balloon is larger than the crimped thv off the balloon and take care if it's decided to retrieve.No ifu or 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 for "general risks failure frame damage" was confirmed based on the returned device.No potential manufacturing non-conformance was identified.A review of the lot history, complaint history, dhr, and manufacturing mitigations did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.Additionally, a review of the ifu and training manual revealed no deficiencies.As reported, "it was attempted to perform the valve alignment in a straight section of the aorta, but due to the anatomy was very difficult, and it was not possible to get the valve between the alignment markers.Then a bent valve frame strut was detected, and therefore it was decided to retrieve the valve back into the esheath and remove all devices as a single unit".Additionally, it was noted there was calcification and tortuosity within the descending aorta.Per the training manual, "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 1-2 centimeters while advancing the thv/delivery system", and "do not over-manipulate the sheath at any time".Due to the difficulty of anatomy (calcification and tortuosity) and valve alignment difficulty, the valve strut could potentially interact with calcification and tortuosity anatomy and resulted in a bent strut during the valve alignment manipulation.Furthermore, additional excessive force was likely applied during the delivery system (with crimped valve) retrieved through the sheath, and the bent strut likely caught within the sheath as indicated by the puncture sheath, and it caused further the strut to bend.In this case, available information suggests that patient factors (calcification/tortuosity) and/or procedural factors (excessive device manipulation/retrieve crimped thv with bent strut) may have contributed to the complaint event.However, a conclusive root cause was unable to be determined at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No labeling or ifu/training inadequacies were identified.Therefore, no corrective or preventative action 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: 11413637
• MDR Text Key: 248858513
• Report Number: 2015691-2021-01653
• 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
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

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: 11/20/2022
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1