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

Model Number 9610ES14

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

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

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by an edwards (b)(6) affiliate, during a transfemoral tavr procedure with an unknown edwards thv valve, during insertion of the commander delivery system and valve into the esheath, there was resistance experienced in the extern iliac.Upon removal of the esheath, it was noticed that the distal tip was damaged.The system was removed as a whole unit with no surgical cut-down needed.There was no patient injury and no actions were taken.Per medical opinion, the root cause of the resistance may be due to calcification the on access site.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation, however, a device history record (dhr) review was done, and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.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.Photos were provided by the reporting facility of the device, review of the images show the esheath distal tip opened along the axial score line but was torn radially along the distal edge of the liner.The liner was also fully expanded as designed.The following instructions for use (ifu) were reviewed to capture relevant device preparation and use: ifu for esheath, ifu for commander delivery system, device preparation manual, and procedural training manual.Based on this review, there were no ifu/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 complaints for difficulty advancing through esheath and esheath distal tip torn were confirmed upon review of the provided imagery.The complaint description states, 'there were no issues inserting the esheath in the patient, but it was difficult to insert the ds through it (specially in extern iliac).But femoral access was good for a 14f.When the esheath was retrieved, it was noticed that it was broken in distality.' per evaluation of the provided imagery, the sheath distal tip was observed to be torn radially along the distal edge of the liner.While a definitive root cause was unable to be determined, previous investigation indicated that the tear is attributed to improper tip expansion, resulting in interference between the valve and sheath tip.As such, it is possible that improper tip expansion contributed to the reported delivery system advancement resistance and the distal tip tear.Furthermore, the complaint description reports the patient had calcification present in the access vessel.Per the procedural training manual, 'push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification.' the presence of calcification within the access vessel can create a constrained condition and prevent the sheath from fully expanding, increasing the necessary push force to advance the delivery system through the sheath.As such, available information suggests that reported resistance and distal tip tear may be related to improper expansion of the sheath tip during thv advancement and/or patient factors (calcification).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 corrective or preventative actions are required.

• Brand Name: EDWARDS ESHEATH INTRODUCER
• 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: 13609364
• MDR Text Key: 286269718
• Report Number: 2015691-2022-04171
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2023
• Device Model Number: 9610ES14
• Device Lot Number: 64027673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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