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

Model Number 914ESPA

Device Problem Material Integrity Problem (2978)

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

Event Date 03/27/2024

Event Type  malfunction  

Event Description

As reported by the field clinical specialist (fcs), during implant of a 20 mm sapien 3 ultra resilia valve in the aortic position, 14f esheath+ would not traverse through the iliac.It was removed and noted that the device flared at the tip.The clear end of the sheath hit some calcium and had a small tear creating a flap that was sticking up.It didn't extend down into the blue portion of the sheath.A second sheath was used without any further issues.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from an engineering evaluation.The complaint investigation will be conducted, using an evaluation summary written by edwards lifesciences and triage level 2, in accordance with temporary change authority (tca).Since the technical summary is applicable to this complaint, a dhr review is not required.No evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.Per the rmw for the edwards esheath introducer set and esheath+ introducer set, sheath insertion/advancement difficulty is an identified hazardous situation associated with the transcatheter valve replacement procedure.To promote successful introduction of the esheath/esheath+ and introducer, design requirements and drawings include smooth transition between the sheath tip and introducer shaft (with a nominal defined gap), sheath tip and shaft materials selection and sheath/introducer dimensions, 0.035'' guidewire compatibility, adequate sheath-introducer locking feature (esheath+ only), and no premature opening of the distal tip or seam of the esheath/esheath+ during introducer insertion.Esheath and esheath+ were verified and validated including for lubricity and durability of the hydrophilic coating.Mitigation's include visual and dimensional inspections of the sheath, introducer, and hydrophilic coating, sheath kink testing, guidewire compatibility, and bond strengths.Edwards also provides guidance and instructions on visualizing and assessing vasculature, device prep, and proper insertion techniques in the instructions for use (ifu) and training/refresher training materials, including adequate hydration of components, use of 0.035'' guidewire, and appropriate orientation of the esheath/esheath+ seam in the vasculature.Training materials also note that insertion push force can vary due to the angle of access and insertion, vessel diameter, tortuosity, and degree of calcification.Review of prior closed similar complaints that were able to be confirmed indicates that patient and/or procedural factors can contribute to sheath insertion/advancement difficulty.Furthermore, the review did not identify an edwards related defect that may have contributed to the complaints.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.Furthermore, more than one of these factors can compound and further lead to difficulty during sheath introduction into patient anatomy and/or lead to consequential damage of the sheath.The complaint for inability to introduce sheath and distal tip damage were unable to be confirmed.Investigation results suggests that patient factors (calcification) may have caused or contributed to the inability to introduce the sheath, while patient factors (calcification) and/or procedural factors (increased push force) may have caused or contributed to the sheath distal tip damage.In this case, it was reported that 'the clear end of the sheath hit some calcium and had a small tear creating a flap that was sticking up'.It is likely that calcium within the patient access vessel acted as a physical obstacle that, when obstructing passage, resulted in a higher push force in attempts to overcome and caused sheath distal tip damage.No edwards defect or manufacturing non-conformance that would have contributed to the reported event was identified.No ifu/training deficiencies were identified.Therefore, no further escalation (capa/scar/pra/fca) is required.All complaints are reviewed against control limits.

• Brand Name: EDWARDS ESHEATH INTRODUCER SHEATH
• 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: 19097495
• MDR Text Key: 340570789
• Report Number: 2015691-2024-02809
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)250517(11)230518
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPA
• Device Lot Number: 65051154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2023
• 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 Outcome(s): Required Intervention