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

Model Number 9610ES16

Device Problems Material Puncture/Hole (1504); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

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

Event Date 01/15/2024

Event Type  malfunction  

Event Description

As reported by an edwards lifesciences affiliate in italy, regarding an implant case of a 29mm sapien 3 valve in aortic position by right transfemoral approach.During procedure, unusual resistance was noticed when advancing the commander delivery system through the 16f esheath and the valve got stuck inside the sheath.Decision was made to remove the sheath, valve and delivery system from the patients body.A new 29mm sapien 3 valve was crimped and a esheath plus was inserted into the right femoral.The esheath plus showed an anomaly (similar to kinking) at the same location this initial resistance was observed.Therefore, the second 29mm commander delivery system and 29mm sapien 3 valve prepared were not inserted into the esheath plus.It was decided to use the left femoral artery as the access site.A third sheath and the second commander delivery system and valve were used to successfully implant the valve.No patient complications occurred.The patient was fine at the end of the procedure.As per medical opinion, the root cause of the event may be the access puncture could have been high, at the level of the inguinal ligament and that this was precisely what could somehow cause the resistance.As per the preliminary evaluation of the available photos of the first devices used, it was observed the esheath shaft was damaged and there was a valve strut slightly bent.The devices were returned for evaluation.As per the pre-decontamination evaluation, it was found that the esheath damaged was shaft punctured and the distal tip torn during functional testing.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Investigation is underway.

Manufacturer Narrative

The device was returned for evaluation.The returned device was visually examined, and the following was observed: sheath shaft noted curved.Sheath liner partially expanded (with a length of 10cm from strain relief.Distal tip unopened.Crimped valve stuck at sheath shaft at 1.8cm from strain relief.One bent strut outwards at inflow side.Sheath shaft puncture at crimped valve location.Sheath shaft kinked at 4cm and 9cm from strain relief.Partial delamination at first kink location.Functional testing was performed.The associated commander delivery system (cds) was advanced through the sheath and the sheath expanded, as designed.However, the distal tip was torn after cds advancement.Based on that, the following observations were made: distal tip is torn radially along distal edge of the liner.Distal tip opened along the axial score line.Imagery was reviewed and the following was observed: crimped valve stuck inside the sheath shaft.One strut protruding the sheath shaft.One bent strut outwards at inflow side.The reported events were confirmed per evaluation of the returned device.However, no manufacturing nonconformance was identified during evaluation.Review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were noted during device unpacking or preparation.Per evaluation of the returned device, the valve was stuck in the sheath shaft.Additionally, the sheath shaft was noted curves and two kinks were observed on sheath shaft.In this case, kinks or curvature along the sheath shaft can be indicative of the presence of vessel tortuosity.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.As such, available information suggests that patient factors (tortuosity) may have contributed to the complaint event.Per evaluation of the returned device, the sheath shaft was punctured and one bent strut outwards at inflow side were observed.In this case, it is possible that additional device manipulation to overcome the reported 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 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.As such, available information suggests that patient factors (tortuosity) and/or procedural factors (valve caught on sheath, excessive manipulation) may have contributed to the complaint event.During evaluation of the returned device, the distal tip torn while advancing the commander delivery system through sheath.The failure mode is characteristic of sheath tip tear events as described in (b)(4).While a definitive root cause was unable to be determined, previous investigation indicated that the tear is attributed to improper tip expansion, resulting in interference between the valve and sheath tip.As such, it is possible that improper tip expansion contributed to the experienced delivery system advancement resistance at the sheath distal tip and the distal tip tear.As such, the failure mode improper expansion of the sheath tip during thv advancement may have contributed to the complaint event.However, a definitive root cause is unable to be determined.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: 18988920
• MDR Text Key: 338735801
• Report Number: 2015691-2024-02359
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103193244
• UDI-Public: (01)00690103193244(17)250808(11)230809
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• 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: 65220844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• 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 Age: 77 YR