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

Model Number 914ESPA

Device Problem Material Puncture/Hole (1504)

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

Event Date 05/05/2022

Event Type  malfunction  

Event Description

As reported by field clinical specialist, during the placement of the 26mm sapien 3 ultra in a pre-existing non-edwards surgical mitral valve, the initial sheath was inserted with the seam up.A valve strut caught and pierced expandable portion of sheath.The esheath+ and delivery system were removed.A new sheath was inserted with the e up as directed.A new delivery system was prepped along with a new valve and delivered without incident.The case was successful, and the patient is doing well.The devices were discarded.There was no injury to the patient.When asked if there was a bent strut on the valve, the fcs indicated the pictures show one strut just went straight through the clear part of the sheath.It did not bend at all.It appeared that the valve strut completely punctured the clear liner portion of the esheath+.It punctured it in the expandable portion about midway down the sheath.The fcs expanded the sheath with the pre expander tool during prep.When asked if there was resistance when advancing the valve on the delivery system through the sheath, the fcs indicated initially, no.The sheath was in the patient 180 degrees opposite normal placement.The valve stopped advancing about midway through the sheath at a bend in the vessel.The operator felt resistance at that point and stopped.To avoid any injury they decided to remove the system and sheath and start over with the sheath in normal position.

Manufacturer Narrative

The device is no available for return.Investigation is ongoing.The devices were discarded.

Manufacturer Narrative

As no product was returned for evaluation, no visual inspection, functional testing or dimensional testing could be performed.A lot history review of the related work order was performed and revealed no other complaints relating to the relevant complaint code.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.The work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.Two photos provided show close-up images of the valve puncturing through the sheath liner.The third photo shows the liner puncture was in the middle of the shaft with the distal portion of the sheath liner remaining unexpanded and tip unopened.The esheath+ ifu, the esheath+ with commander sapien 3 ultra preparation training manual, the esheath+ with commander sapien 3 ultra procedural training manual, and the commander sapien 3 ultra valve-in-valve mitral position supplemental training manual were reviewed.The training manual states, ''insert the sheath with the edwards logo facing upward so the seam remains down to ensure proper sheath performance''.No ifu/training deficiencies were identified.A complaint history review on confirmed device complaints (returned and no product returned) from june 2021 to may 2022 for the esheath+ (all models and sizes) was performed with the codes identified as related.Prior closed complaints with any of the codes below were reviewed for similar events and root cause identification.Of the root causes identified, procedural factors (valve caught on liner) is potentially applicable to the complaint event.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 puncture was confirmed through evaluation of returned imagery.However, no manufacturing non-conformances were identified in the evaluation.Reviews of the lot history, dhr, and complaint history showed no indication a manufacturing non-conformance contributed to the event.No ifu/training manual deficiencies were identified.As no damages on the sheath were observed or reported during device preparation, the liner damage was likely not present out of the packaging.As reported, ''during the placement of the 26mm sapien 3 ultra in a pre-existing non-edwards surgical mitral valve, the initial sheath was inserted with the seam up''.The training manual states, ''insert the sheath with the edwards logo facing upward so the seam remains down to ensure proper sheath performance'' and ''orient the delivery system with the flush port pointing away and the edwards logo facing down''.Although the delivery is intended to be used with the edwards logo facing down for valve placement in the mitral position (delivery system needs to flex in the opposite direction compared to placement in the aortic valve), the sheath is still intended to be used with the edwards logo facing up for proper performance within femoral access.If the sheath is not oriented correctly in the vessel, the valve can negatively interact with the liner as it expands during tracking through the sheath resulting in the valve to catch on the liner, puncturing it.Available information suggests procedural factors (use error [improper sheath orientation], valve interaction with liner) contributed to the event.Since no product non-conformances or ifu/training manual deficiencies were identified, no escalation to a pra was required.Since no edwards defect was identified, no corrective or preventative actions are required.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.No corrective or preventative actions are required.

• Brand Name: EDWARDS ESHEATH PLUS
• 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: 14497856
• MDR Text Key: 300452109
• Report Number: 2015691-2022-05877
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240306(11)2203072164252143
• 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
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2024
• Device Model Number: 914ESPA
• Device Catalogue Number: N/A
• Device Lot Number: 64252143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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