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

Model Number 916ESPA

Device Problems Peeled/Delaminated (1454); Material Integrity Problem (2978); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

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

Event Date 11/15/2023

Event Type  malfunction  

Event Description

As reported by a field clinical specialist, during a transfemoral aortic valve replacement procedure, there was a lot of push force noted when the29mm sapien 3 ultra resilia valve was inserted into the sheath.Once the valve exited the sheath, a bent strut was noted.The physician attempted to pull the valve back in the sheath but was unable to.The team decided to deploy the valve in the aortic valve.The strut opened up and there was no harm to the patient.The delivery system and sheath were removed.Upon removal of the sheath, the clear liner and strain relief were noted to be torn.The sheath was received for evaluation and during pre-decontamination the distal tip was observed to be torn and and there were liner strands present.

Manufacturer Narrative

Initial mdr, under section h10: this is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no.The investigation for this event is ongoing.

Manufacturer Narrative

Section h6 component, type of investigation, investigation findings and investigation conclusions have been corrected.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.The device was returned for evaluation.Slight curvature was noted on the sheath shaft.There was a tear noted on the strain relief.A liner strand was protruding through the strain relief tear.The strain relief was removed and the liner was torn under the strain relief.Due to the condition of the returned device, no functional testing or dimensional testing was able to be performed.Imagery was provided that showed calcification and tortuosity present in the patient's right access vessel.The patient had undersized vessels.One bent strut was observed on the inflow side of the valve.The bent strut was corrected after deployment.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.It has been established through extensive complaint investigations, that events reporting resistance during delivery system insertion/advancement through the sheath and potential valve frame damage using the s3u/s3ur valve configuration have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have been due to vessel tortuosity, calcification, undersized vessels, and/or steep insertion angle.In addition, valve frame and/or sheath damage can be a result of increased push force and any excessive device manipulation or sheath-valve interaction.Therefore, it is likely that these patient/procedural factors may have caused or contributed to the difficulty advancing the delivery system through the sheath and valve frame and/or sheath damage.In this case, the investigation confirmed difficulty advancing through sheath, strain relief damage, sheath liner strands and liner torn.Available information suggests that patient factors (calcification, tortuosity, undersized vessels) likely contributed to the event as calcification, tortuosity, and undersized vessels were observed in the patient's access vessels.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.Additionally, the associated valve has a bent strut.It is possible that additional device manipulation to overcome the resistance may be applied during the procedure resulting in damage to the sheath.During delivery system advancement through a challenging pathway, it is possible that the devices may not be coaxially aligned.This can lead to the crimped valve to catch onto the sheath hdpe, liner, and/or strain relief and lead to damage.Excessive device manipulation applied to overcome the resistance can further damage the sheath through continued interaction between the crimped valve and sheath.Vessel calcification and/or tortuosity if present can exacerbate the interaction between the crimped valve and sheath.Sharp calcified nodules can directly weaken the sheath shaft making it more susceptible to damage as the delivery system with crimped valve is advanced through.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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18440740
• MDR Text Key: 331985842
• Report Number: 2015691-2024-00034
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)250522(11)2305232165083(01)00690103215472(17)250522(11)230523
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 916ESPA
• Device Lot Number: 65083852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• 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: Female
• Patient Weight: 79 KG