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

Model Number ESHEATH UNKNOWN

Device Problems Material Puncture/Hole (1504); Failure to Advance (2524); Material Twisted/Bent (2981)

Patient Problem Perforation of Vessels (2135)

Event Date 02/15/2022

Event Type  Injury  

Event Description

As reported by a field clinical specialist, during a subclavian/axillary tavr procedure of a 26 mm sapien 3 ultra valve in the native aortic valve, the first 14f sheath kinked and caused the 26 mm valve on the delivery system to break through the 14f sheath and get stuck.A second system was prepped and the entire first system was removed and a new sheath placed, then a second 26mm valve delivery system was successfully deployed.It was noticed there was a perforation in the left subclavian and a 6x29 mm stent was placed over the dissection and sealed the vessel with a good result.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information base on the device evaluation.The following sections of this report have been updated: corrected e.4 initial reporter also sent the report to fda.Voluntary medwatch was received, uf/importer report # (b)(4).Please reference frame strut damage manufacturer report no:2015691-2022-05141.Additional information received from the medwatch: main access was taken though the left axillary artery, during procedure difficulty to advance was noted.The system was removed and a strut of the valve had torn through the esheath and a small part of it was protruding.It was felt that the axillary artery may have sustained an injury from this.A new system was used for the new valve.The patient is stable and was discharged home.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 component codes and investigation conclusions and added new information to h.6 type of investigation and investigation findings.The esheath plus 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.Imagery was not provided for review.During manufacturing, the device undergoes multiple 100% inspections.In addition, the work order underwent functional product verification testing on a sampling basis as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath plus usage.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of the risk management documentation was performed, and 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 complaints 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 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.In this case, ''as reported by a field clinical specialist (fcs), during a subclavian/axillary tavr procedure of a 26 mm sapien 3 ultra valve in the native aortic valve, the first 14f sheath kinked and caused the 26mm valve on the delivery system to break through the 14f sheath and get stuck''.Additional case notes state that once the system was removed a bent strut was observed protruding through the seam of the sheath.As resistance was experienced, the devices were potentially manipulated in an attempt to overcome it.This likely led to the crimped valve to catch onto the liner and puncture it.Per training manual, ''access characteristics that would preclude safe placement of sheath such as severe obstructive calcification, severe tortuosity or vessel diameters less than 5.5 and 6.0 mm''.Although limited information was provided regarding patient factors, it is possible that vessel tortuosity may have been present as it would have subjected the sheath to suboptimal angles during insertion.This could have also been compounded with a potentially steep insertion as such, available information suggests that procedural factors may have contributed to the reported event.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 ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• 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: 13726492
• MDR Text Key: 287403402
• Report Number: 2015691-2022-04370
• Device Sequence Number: 1
• Product Code: DYB
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESHEATH UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male