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

Model Number 914ESPA

Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from a field clinical specialist, a patient underwent right subclavian tavr with a 26mm s3ur valve.During the introduction of the delivery system through the 14f esheath, the right subclavian was very tortuous and the delivery system broke through the clear expanding portion of the 14f esheath.The valve was able to be deployed.No patient injuries were found.The patient left in stable condition.

Manufacturer Narrative

Supplemental report submitted to include additional information received through follow-up.

Manufacturer Narrative

Supplemental report submitted to include added code per post-deco engineering evaluation and completion of the engineering evaluation.Added h6 device code and component code.The device was returned for evaluation and an engineering evaluation was performed.The following visual examinations were noted on the returned device: sheath curvature.Liner is fully expanded as designed.Liner tear on entire length along sheath shaft.Sheath shaft damaged 2.25'' from the tip.Sheath shaft has kink 4'' from the tip.Partial liner delamination in damaged region 5'' from tip.Distal tip split.Scratches along the shaft distal tip.Liner thickness was measured along the liner tear and all measurements were found to be within the specification.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 the failure mode is not required at this time.The complaints of sheath liner punctured, sheath damaged, sheath distal tip split were confirmed by evaluation of the returned device.However, no manufacturing non-conformance was identified during the evaluation.As no lot number was provided, a review of the dhr and lot history was unable to be performed.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were noted during device unpacking or preparation.As reported, ''as reported, during the introduction of the delivery system through the 14f esheath, the right subclavian was very tortuous and the delivery system broke through the clear expanding portion of the 14f esheath''.Per product evaluation, sheath curvature and shaft kink suggesting presence of vessel tortuosity, and distal tip scratches and distal tip split suggest interaction with calcification.Additionally, per imaging evaluation, tortuosity and calcification were present in the patient's access vessels.Lastly, post-procedural device imagery revealed sheath shaft curvature, an indication of presence of tortuosity.Per the training manual, ''push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification.'' calcification can damage the exposed portion of the sheath liner.Damage along the liner could lead to immediate cutting/tearing or could weaken the liner.A weakened liner can tear during advancement or retrieval of the delivery system.Vessel angulation can create suboptimal angles during delivery system advancement through the sheath.Which can lead to non-coaxial alignment between the devices and lead to friction.It is likely that the delivery system with crimped valve interacted with the liner and shaft from the non-coaxial alignment resulting in the torn liner and damaged shaft.Additionally, sharp nodules of calcification can damage the tip (split) through direct interaction.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (valve interaction with liner) may have contributed to the liner puncture, procedural factors (valve interaction with sheath) may have contributed to the sheath damage, and patient factors (calcification) may have contributed to the sheath distal tip split.However, a definitive root cause is unable to be determined at this time.No manufacturing non-conformances that would have contributed to the complaint event were identified.Available information suggests that (calcification) may have contributed to the complaint event.No device or labeling problem was identified during the evaluation.Therefore, no further escalation is required.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.

• Brand Name: ESHEATH PLUS 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: 18460213
• MDR Text Key: 332734698
• Report Number: 2015691-2024-00118
• Device Sequence Number: 1
• Product Code: DYB
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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