MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH PLUS; INTRODUCER, CATHETER

Model Number 914ESPA

Device Problem Material Rupture (1546)

Patient Problem Great Vessel Perforation (2152)

Event Date 04/13/2022

Event Type  Death  

Event Description

As reported by field clinical specialist, during the procedure, the physician felt an unusual movement while advancing a 23 mm sapien 3 ultra through a 14 f esheath+.As the physician was advancing the valve through the sheath, he described a jump or sudden give in the system.When the examined where the valve was in the sheath, the valve and delivery system had buckled laterally out of the sheath, possibly puncturing or tearing a hole in the abdominal aorta.There was a sudden loss of blood pressure and emergency measures were initiated to try and save the patient.After approximately 1 hour of efforts there was a consensus from the team that the patient would not survive and terminated life saving measures.After speaking to the physician, he felt the valve had become stuck in the sheath after the sudden jump because he was unable to advance or retract the valve within the sheath.Since the patient was bleeding from the aorta, a coda balloon was inserted in the opposite leg from the tavr side and inflated in the thoracic aorta to mitigate bleeding from the injury site.The team was unable to establish access to the subclavian artery to proceed with any type of percutaneous intervention, endovascular stent grafting, to repair the injured aorta.Since the valve/ds and coda were occupying the access from below, coupled with the inability to gain subclavian access from above there was no way to proceed with implanting (or removing) the valve or implant the endovascular grafts, there was no way to repair the damaged aorta.The patient expired.Additional information indicated the devices will not be returned.The devices were still in the patient when she expired.The hospital may or may not return them at all until they've conducted their review of the case.The sheath was on the right side.The delivery system met the most resistance when it was about 2/3 of the way through the esheath.The 22f expansion tool was used and there was no difficulty during expansion of the esheath+ during prep.The fcs reported he was only able to see the delivery system while the physician was using x-ray.The delivery system was kinked, like the letter v, at the point where the flex catheter and valve are touching.There was no damage visualized on the valve or sheath, as the fcs was only able to see the ds during that quick imaging.The loader was fully in the sheath.The insertion angle was about 30 degrees, it looked normal to the fcs.The vessel was pre-dilated, the physician used the 16 f dilator that comes with the esheath+ kit.Additionally, the physician did not comment on resistance prior to feeling the "jump".The fcs stated there was no more resistance than anticipated.There was some calcium in the vessel, so some resistance was expected, but not struggling more than expected.The puncture occurred on the sheath distal to where the expansion tool would have terminated.Per the fcs, there was thought to be an aneurysmal section in the vessel.The fcs commented the amount of force might have translated to a lateral motion at this point of the vessel.

Manufacturer Narrative

Investigation is ongoing.Device kept by hospital.

Manufacturer Narrative

The device was not returned for evaluation, therefore no functional testing, dimensional testing, or visual inspection could be performed.A review of imagery was performed, and calcification and tortuosity was present in patient's access vessel.The work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.Difficulty advancing the commander delivery system with s3u crimped valve through the esheath resulting in a high push force has previously been documented in a product risk assessment (pra).Manufacturing mitigations/controls relevant to the issue are captured in a pra.The review of these documents confirmed that these mitigations remain applicable to the manufacturing of the complaint device.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint regarding the liner puncture, a manufacturing mitigation review is not required.The ifu/training mitigations/controls relevant to the reported issue (difficulty advancing the commander delivery system with s3u crimped valve through the esheath resulting in a high push force and esheath damage) is captured in pra.The following guidelines and instructions provided to physicians on how to properly handle, prepare, and use the thv and system in the ifu and training materials remain similar between the esheath and esheath+: 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.Ifu for esheath+ introducer set and device preparation training manual were reviewed.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 resistance and puncture were unable to be confirmed without the returned device or procedural imagery.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, review of the device history record (dhr) and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device unpacking or preparation.Case notes report the resistance was encountered, ''the delivery system met the most resistance when it was about 2/3 of the way through the esheath''.Returned patient imagery showed calcification and tortuosity present in the patient's access vessel.Calcification can reduce the vessel diameter and create a constrained condition for the sheath to fully expand, while tortuosity can create suboptimal angles and lead to non-coaxial alignment between the delivery system and sheath.These patient factors could have contributed to increasing resistance, which requires a higher push force to overcome.Available information suggests that patient factor (calcification, tortuosity) may have contributed to the reported event.As reported ''the puncture occurred on the sheath distal to where the expansion tool would have terminated''.Likewise, case notes report the delivery system was kinked, ''like the letter v, at the point where the flex catheter and valve are touching''.It's possible that non-coaxial insertion of the devices could have led to the valve and delivery system catching onto the sheath liner and creating the puncture in the liner.Available information suggests that procedural factors (non-coaxial insertion) may have contributed to the reported event.The complaint resistance was unable to be confirmed.However, no manufacturing non-conformances that would have contributed to the complaint event were identified.Available information suggests that patient factor (calcification, tortuosity) may have contributed to the reported event.No labeling/ifu deficiencies were identified.A product risk assessment (pra) was previously initiated to investigate the cause and assess the risks associated with the reported event and a corrective action preventative action (capa) was previously initiated to capture further investigation and corrective/preventative activities.The liner puncture was unable to be confirmed.However, no manufacturing non-conformances that would have contributed to the complaint event were identified.Available information suggests that procedural factor (non-coaxial insertion) may have contributed to the reported event.No labeling/ifu deficiencies were identified.Therefore, no corrective or preventative actions, nor pra is required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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 ESHEATH PLUS
• Type of Device: INTRODUCER, CATHETER
• 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: 14319871
• MDR Text Key: 291192723
• Report Number: 2015691-2022-05610
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)231206(11)2112062164129925
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• 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: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2023
• Device Model Number: 914ESPA
• Device Catalogue Number: N/A
• Device Lot Number: 64129925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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 Outcome(s): Death; Required Intervention
• Patient Age: 98 YR
• Patient Sex: Female