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

Model Number 916ESP

Device Problems Material Puncture/Hole (1504); Difficult to Advance (2920); Material Integrity Problem (2978)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

As reported, it was a case of an implant of a 29mm sapien 3 valve, in aortic position by transfemoral approach.During procedure, the 18fr dilator was not used to pre-dilate the access vessel.After the esheath plus insertion, it was detected that the non-expandable part of the esheath plus started to get "wrinkles" and could not be completely inserted.Nevertheless, it was decided to proceed with the procedure.There was no difficulty when advancing the commander delivery system (ds) through the esheath plus and the valve was implanted successfully.However, during withdrawal, difficulties were noted since the balloon of the commander ds could not be pulled back into the esheath plus.More volume was aspirated into the inflation device which helped the withdrawal of the commander ds.Upon removal, it was observed that the guide wire exited the sheath through a liner punctured.There was no harm to the patient and no blood transfusion was needed.

Manufacturer Narrative

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

Manufacturer Narrative

The device 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 provided from the site and revealed the following: guidewire was protruding the sheath shaft.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.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.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.In this case, the complaints for difficulty to introduce the sheath and esheath damage were unable to be confirmed.However, the complaint for liner puncture was confirmed based on the evaluation of the provided imagery.Available information suggests that patient factors (calcification, tortuosity) may have caused or contributed to the difficulty to introduce the sheath and liner puncture as the degree of tortuosity and calcification in patient's access vessel was mild.While procedural factors (excessive manipulation) may have caused or contributed to the sheath/introducer damage.Calcification can damage the exposed portion of the sheath liner, which can lead to immediate cutting, tearing, or weakening of the liner.A weakened liner can also tear during advancement or retrieval of the delivery system or balloon catheter.Moreover, vessel tortuosity can create suboptimal angles during delivery system or balloon catheter advancement/retrieval through the sheath.Non-coaxial alignment can cause the delivery system or balloon catheter to catch onto the sheath liner and tear it upon advancement/retrieval.Patient and procedural factors such as calcified, tortuous, or undersized patient vasculature and/or a steep insertion angle can create a challenging pathway for sheath introduction.Sharp, calcified nodules within the patient access vessel can act as physical obstacles, while undersized vessel diameters can constrain the sheath increasing friction and leading to higher push force.In addition, vessel tortuosity and a steep device insertion angle can induce stress to the sheath shaft causing it to kink or bend and require a higher push force to navigate.Inadequate or constrained patient access site can also cause difficulty and lead to the strain relief to catch onto the anatomy as it is advanced.As a result, the operator may apply excessive manipulation or increased push force to overcome the difficulty, which may lead to sheath tip or shaft damage, including premature opening of the tip or lifting of the liner.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: 18563864
• MDR Text Key: 333498701
• Report Number: 2015691-2024-00534
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 916ESP
• Device Lot Number: 65313976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2023
• 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 Sex: Male