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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2023

Event Type  malfunction  

Event Description

As reported by the field clinical specialist, during surgery, there was resistance pushing the valve through the partially expandable portion of the sheath.The sheath with delivery system was withdrawn and it was observed that a valve strut extruded through the sheath wall.A second system with a 16fr dilator was used without issues.There was no patient injury.

Manufacturer Narrative

Investigation is ongoing.Device not returned.

Manufacturer Narrative

The product was not returned; therefore, a no product return investigation was completed.As a device was not returned, visual inspection, functional testing, and dimensional testing were unable to be done.Imagery was provided by the site and revealed one (1) bent strut (approximately 90 degrees) exposed through sheath liner close to the strain relief transition.Review of the work orders above did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed using the valve serial numbers from related work order and revealed no other complaints relating to the relevant complaint codes.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.The ifu relevant to the reported issue was reviewed.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 was confirmed based on provided imagery.A review of the dhr and lot history, and manufacturing mitigations 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 physician had difficulty pushing the valve through the partially expandable portion of the sheath.The sheath was back up and it was then noticed that the tines had extruded through the sheath wall'.Per training manual, '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.' furthermore, as stated in 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 cm while advancing the thv/delivery system', and 'do not over-manipulate the sheath at any time'.In this case, additionally provided information disclosed that patient had mild tortuous anatomy.The presence of tortuosity can create a challenging pathway during delivery system advancement, leading to resistance and high push force.So, if excessive force was applied to overcome the high push force, it could have caused the thv struts to interact with the sheath shaft, leading to frame damage as reported.As such, available information suggests that patient factors (tortuosity) and/or procedural factors (excessive device manipulation, high push force) may have contributed to the complaint event.Pra was previously initiated to investigate and assess the risks associated with frame damage.To address the issue, capa was initiated to drive corrective/preventive actions.The risks outlined in the product risk assessment (pra) remain the same.The pra documents the difficulty advancing the delivery system through the sheath, resulting in 'difficulty to introduce delivery system and advance through sheath, resulting in procedural delay', which did occur during this event.Corrective action preventative action (capa) has previously been initiated to capture further investigation and corrective/preventative action activities associated with insertion of commander delivery system with s3u through the esheath resulting in frame damage.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

• 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
• 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: 16291723
• MDR Text Key: 309291828
• Report Number: 2015691-2023-10542
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)250622
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX26A
• Device Catalogue Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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 Age: 84 YR
• Patient Sex: Male