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

Model Number 9750TFX23A

Device Problem Fracture (1260)

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

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported, during a transcarotid tavr case, resistance was noted while advancing the first 23mm sapien 3 ultra valve through the 14f esheath plus when the valve reached the partially expandable portion of the sheath.The valve struts bent backwards and were now exposed.The next push by the surgeon, which was much easier at this point, tore down through the sheath splitting the seam open.The team was able to get control of bleeding quickly.The first valve and sheath were quickly removed and a new system was prepped.A second valve went in smoothly without any issues.There was no major blood loss or arterial damage.The sheath was damaged and split outside of the right carotid artery.The patient did well and was stable throughout the procedure.Vessel diameter measured approximately 6-6.5mm.

Manufacturer Narrative

Added h.6 type of investigation and investigation findings.Corrected h.6 investigation conclusions.The device was not returned for evaluation.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed not other reports of valve frame damage from this lot.During manufacturing of the sapien 3 ultra valve, the valve and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.Within the ifu and training documents the users are instructed on how to screen patients to ensure adequate vessel access and to reduce vascular complications.In addition, a step-by-step instruction on how to insert and advance a delivery system through the sheath including mitigation steps and best practices to address high push force are provided.The users are instructed to correctly orient and lock the delivery system in default position before insertion and for the loader to be fully advanced into the sheath.Insertion force through the partially expandable portion can be higher than the push force through the fully expandable portion, and in expectation of high friction, use short movements and push delivery system closer to sheath hub.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 cm while advancing the thv/delivery system.If push force is too high or valve and sheath are damaged or valve is still stuck, remove valve and sheath together as a single unit and replace, and do not over-manipulate the sheath at any time.In case of vascular injury, vascular complication management instructions are included for resolution.The esheath+ introducer set also includes the expansion tool that is used to pre-expand the partially expandable area of the sheath prior to procedural use to facilitate the advancement of delivery system through this region.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.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.A product risk assessment (pra) was previously initiated to investigate and assess the risks associated with valve frame damage for s3u valves with commander delivery system and esheath configuration.This pra continues to apply to esheath+ as there are no significant changes related to the sheath shaft.This includes material composition, manufacturing process, inspection, and testing.To address the issue, a corrective action preventative action (capa) was initiated to drive corrective/preventive action activities associated with the insertion of the commander delivery system with s3u valve through the esheath, resulting in frame damage.The corrective action is intended to reduce, but not eliminate the complaint occurrence.The valve frame damage was confirmed through provided imagery.A review of dhr did not provide any indications that a manufacturing non-conformance would have contributed to the reported event.A review of the ifu and training manual revealed no deficiencies.As reported, ''resistance was noted while advancing the first 23mm sapien 3 ultra valve through the 14f esheath plus when the valve reached the partially expandable portion of the sheath.The valve struts bent backwards and were now exposed.The next push by the surgeon, which was much easier at this point, tore down through the sheath splitting the seam open.Per 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 cm while advancing the thv/delivery system,'' and ''do not over-manipulate the sheath at any time.'' so, if excessive force was applied to overcome mentioned resistance, it could have caused the valve to get caught on the sheath liner resulting in frame damage (e.G.Bent struts) and sheath liner tear, as reported.These patients and/or procedural condition, in conjunction with the exposed apices of the crimped s3u thv, may increase the rate of frame damage.The capa has identified potential areas for s3u design/process improvement to mitigate against the failure.As such, available information suggests that) and/or procedural factors (excessive device manipulation) may have contributed to the reported event.However, a definite root cause is unable to be determined at this time.

• Brand Name: 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 13866219
• MDR Text Key: 292488247
• Report Number: 2015691-2022-04573
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)230803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2023
• Device Model Number: 9750TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female