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

Model Number 9755RSL26A

Device Problem Material Twisted/Bent (2981)

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

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

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 by an edwards field clinical specialist, prior to the tavr procedure, it was noted that the patient had heavily calcified peripheral anatomy.Following dilation of the access vessels, the 14fr esheath plus was advanced without difficulty.High resistance was encountered during the advancement of a 26mm sapien 3 ultra valve and delivery system through the sheath.Once the valve was through the sheath, it was noted that there was a bent frame strut.The valve, delivery system and sheath were removed as a unit.A new sheath, valve and delivery system were prepared and successfully used for the procedure.No injury to the patient was reported.At the time of the report, the patient was in stable condition.The second valve remains implanted in the patient.

Manufacturer Narrative

The 26mm sapien 3 ultra was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imaging was provided and revealed that the patient's access vessel had present of calcification, undersized vessel and tortuosity.The minimum luminal diameter 5.5mm required for a 14f esheath and 6mm required for 16f esheath per instructions for use.A device history record review was performed and did not reveal any manufacturing non-conformance that contributed to the reported event.The ifu/training mitigations/controls relevant to the reported issue (difficulty advancing the commander delivery system with s3u/s3ur crimped valve through the esheath resulting in a high push force and frame damage) is captured in product risk assessment.Edwards has provided guidelines and instructions to physicians on how to properly handle, prepare, and use the thv and system in the ifu and training materials.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.Based on the review, 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 frame damage was unable to be confirmed due to unavailability of returned device and relevant imagery.A review of the dhr did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.As reported, 'the patient was known to have heavily eccentric calcified peripheral anatomy.Esheath and 16fr dilator was advanced with no difficulty, then the 14fr esheath was advanced with not much resistance.When the valve and delivery system was advanced high resistance was met.Once the delivery system was pushed through the high resistance area there was a bent strut on the valve frame.Valve, delivery system, and sheath were all removed as a unit and a new esheath was placed".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'.Additionally, per 3mensio, the patient's access vessel had presence of calcification, tortuosity, and undersized vessels.The presence of calcification, tortuosity, and undersized vessel can create challenging pathway during delivery system advancement, leading to resistance.In this case, it is possible difficulty was encountered during delivery system advancement, so additional manipulation was applied to overcome the resistance.So, if excessive force is applied to manipulate the device, it can lead to the valve struts interacting the sheath shaft and resulted in the strut damage.In this case, available information suggests that patient factors (calcification, tortuosity, undersized vessels) and/or procedural factors (excessive device manipulation, high push force) may have contributed to the complaint event.No labeling or ifu/training inadequacies were identified.A product risk assessment has previously been initiated to capture the risk assessment of difficulty advancing the commander delivery system with s3u/s3ur crimped valve through the esheath resulting in a high push force and frame damage.No corrective or preventative actions are required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA 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: 15992792
• MDR Text Key: 306451999
• Report Number: 2015691-2022-10055
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215816
• UDI-Public: (01)00690103215816(17)250810(11)220811219886139
• 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: 02/06/2023

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 Model Number: 9755RSL26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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: Male