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

Model Number 9610ES16

Device Problem Material Puncture/Hole (1504)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

As reported from germany by our edwards lifesciences affiliate, a 16fr esheath liner was punctured during a transcatheter aortic valve replacement (tavr) procedure.During a transfemoral tavr procedure, there was resistance introducing the 29mm commander delivery system and 29mm sapien 3 valve through the esheath.While the system with valve was advanced through the esheath, the system exited the middle of the expandable part of the esheath via liner puncture, but the tip of the delivery system was still inside the distal tip of the esheath.No forward or backward movement was possible without the potential risk of vascular damage or losing the valve towards the distal tip of the commander.An ima-catheter was advanced through the contralateral side, and it was attempted to place a wire through the intact tip of the esheath to have something in place that might help get the valve back into the esheath inner lumen.The tip of the esheath was completely torn in a longitudinal direction, releasing the valve from its stuck position.The system could then be advanced, and the valve was successfully deployed.Proper valve function was confirmed with fluoroscopy and echo.The esheath was carefully and slowly removed from the femoral artery under constant fluoroscopic control.There was no visible damage to the vessel under fluoroscopy.The patient was stable post-procedure.

Manufacturer Narrative

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: additional code added to h6 component code, additional codes added to h6 type of investigation, corrected h6 investigation findings, corrected h6 investigation conclusions.The event reported is 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.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, 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.The sheath liner puncture was unable to be confirmed.Available information suggests that patient factors (tortuosity, calcification, undersized vessels) likely contributed to the event as the patient had moderate tortuosity and severe calcification at the 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.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.Additionally 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 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: 19093856
• MDR Text Key: 340570125
• Report Number: 2015691-2024-02799
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103193244
• UDI-Public: (01)00690103193244(17)251023(11)231024
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610ES16
• Device Lot Number: 65373468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2023
• 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