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

Model Number 914ESPA

Device Problem Difficult to Advance (2920)

Patient Problem Vascular Dissection (3160)

Event Date 10/12/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.H3 other text : the device was not returned for evaluation.

Event Description

As reported by a field clinical specialist during a transfemoral tavr procedure with a 20mm sapien 3 ultra valve in the aortic position a 16f dilator was first introduced to dilate right common femoral/iliac vessel, and lubricant was introduced inside of the 14f esheath plus prior to insertion of the valve and delivery system.The nominal-prepped valve was introduced into sheath and delivered to mid-external iliac.At this level, resistance was felt by the implanting doctor and multiple attempts were made to cross this area.The doctor elected to remove this valve and sheath as one unit.Upon sheath removal, a disruption of the right common iliac was observed.It was decided to implant a covered stent between the right internal iliac and right femoral head.Percloses were deployed successfully to achieve right sided access hemostasis.The valve was removed and a new valve was successfully delivered and deployed at nominal +2cc into the patient.

Event Description

Per additional information received from the field clinical specialist the initial reporter did not allege the edwards devices were deficient in some way.There were no withdrawal issue and no abnormalities noted with the sheath.The loader was fully inserted into the sheath/sheath housing.The sheath was not inserted at a steep angle.The delivery system was inserted about half-way into the esheath of the expandable portion when resistance was noted.The valve was never inserted past the sheath or into the body.There was no devices damaged.

Manufacturer Narrative

A supplemental mdr is being submitted due to additional information from the field clinical specialist.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The following sections of this report have been updated: b4, g3, g6, h2, and h6.In this case, the reported resistance and subsequent vascular dissection was unable to be confirmed.The event reported is an anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.As device was not returned, engineering was unable to perform any visual, functional, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.A review of edwards lifesciences risk management documentation was performed for this case.Per review, no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.Imagery received showed the patient's access vessel had presence of calcification, tortuosity, and undersized vessel diameters.Available information suggests patient factors (calcification, tortuosity, undersized vessel) likely contributed to the event as imaging evaluation indicates presence of these factors within the patient's access vessel.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Scratches observe-d on the sheath shaft can be indicative of the presence of calcified nodules within the access vessel.Tortuous patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen.Kinks or curvature along the sheath shaft can be indicative of the presence of vessel tortuosity.Undersized vessels (e.G.Due to anatomical variation, pre-existing stent or graft, scar tissue, or fibrosis) can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion and increased resistance during the advancement of the delivery system.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS ESHEATH PLUS INTRODUCER SHEATH 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: 18085327
• MDR Text Key: 327544774
• Report Number: 2015691-2023-17301
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Sex: Female