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

Model Number 916ESPA

Device Problem Material Puncture/Hole (1504)

Patient Problem Perforation of Vessels (2135)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by the field specialist, during the transfemoral transcatheter aortic valve replacement (tavr) procedure with a 29 mm sapien 3 ultra resilia valve, there was resistance felt during insertion of the delivery system with valve through the 16fr esheath+.The delivery system with valve had been advanced to the sheath shaft portion of the esheath+ when the resistance was noted.Upon review of the fluoroscopy, it was observed that the delivery system/sheath had prolapsed into the patient's external iliac artery and resected the artery.The delivery system with valve and sheath were removed.Covered stents were then placed to treat.Once treatment was completed, the procedure proceeded.A new 16fr esheath+, delivery system and valve were prepped.There were no issues reported during the second implant attempt and the valve was implanted successfully.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and includes additional information based on investigation.The following sections of this report have been corrected/updated: h6 (component code, type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data).The events reported are anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into these types of events is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure modes is not required at this time.The device was not returned to edwards lifesciences for evaluation as it was discarded.As a result, no visual inspection, functional testing, or dimensional analysis could be performed.Imagery was provided for evaluation.A review of the provided imagery revealed the crimped valve appeared to have been encapsulated by the patient's vessel tissue while protruding through the torn sheath liner.Additionally, it was noted that there was calcification and tortuosity present in the left access vessel.Per the technical summary, the instructions for use (ifu), current risk mitigations that 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.In this case, the inability to advance the delivery system with valve through the sheath was confirmed via the provided imagery.The available information suggests patient factors (tortuosity and calcification) likely contributed to the event.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 observed on the sheath shaft can be indicative of the presence of calcified nodules within the access vessel.A 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.Non-coaxial advancement of the delivery system through the sheath may lead to resistance.Kinks or curvature along the sheath shaft can be indicative of the presence of vessel tortuosity.Regarding the sheath liner puncture that resulted in perforation of the vessels and covered stents being placed to treat, this event was also confirmed via the provided imagery.The available information suggests patient factors (tortuosity and calcification) and procedural factors (excessive manipulation) may have contributed to the event since there was resistance noted.The presence of calcification and tortuosity can promote suboptimal angles during system advancement, causing the crimped valve to catch onto the sheath liner.Calcification can also damage the exposed portion of the sheath liner directly, which can lead to immediate cutting, tearing, or weakening of the liner.A weakened liner can also tear during advancement of the delivery system when compounded with excessive manipulation, causing the system/crimped valve to exit through the liner.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+ 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: 19134312
• MDR Text Key: 340499326
• Report Number: 2015691-2024-02950
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)251031(11)231101
• 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
• Report Date: 05/23/2024

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 Model Number: 916ESPA
• Device Lot Number: 65400055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/20/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2023
• 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: Male