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

Model Number 9610ES14

Device Problems Break (1069); Peeled/Delaminated (1454); Material Rupture (1546); Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976); Output Problem (3005)

Patient Problems Calcium Deposits/Calcification (1758); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress, a supplemental report will be submitted.

Event Description

Edwards received notification from our affiliate in italy.During a tavr procedure with a 26mm sapien 3 valve, the valve/delivery system was not able to advance in the esheath due to high resistance.The loader was able to be fully inserted.The resistance was felt at about 30 cm into the esheath.The insertion angles was not steep and the degree of calcification and tortuosity was moderate.The delivery system was retrieved through the esheath.A new 26mm sapien 3 ultra valve kit but with a 16fr esheath was prepared and successfully implanted.The patient condition was good.Upon removal, it was noticed a rupture of the expandable sheath, severe kinking of the delivery system and braking of the skirt and folding of the frames of the valve.Per pre-decontamination evaluation observations a liner tear and liner strands were observed on the esheath.As per medical opinion, the failure was due to an abnormal angle towards the inland of the iliac artery with calcifications in the curve.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The 14f esheath was returned to edwards lifesciences with the delivery system inserted through it.The device was visually inspected.The sheath was partially expanded until 16cm distal of the strain relief.A liner tear with length of 7cm begins at distal end of the strain relief.Liner strands were located at tear.Hdpe was found cut 3cm beginning in the soft tip.A second cut was found in the hdpe with length of 1cm beginning in the soft tip.Scratches were also visible on the hdpe at the sheath distal tip.The hdpe was cut after the procedure by the operators per follow-up information.Due to condition of the returned device (liner torn, liner strands), no applicable functional testing was able to be performed.Due to condition of the returned device (liner torn, liner strands), no applicable dimensional testing was able to be performed.Liner thickness was measured along the liner tear as an out of specification result could be indicative of a manufacturing non-conformance.Due to the nature of the tear, measurements were only performed on one side of the tear.Furthermore, the strands were not measured due to their thin/stretched condition.All measurements met specification.Imagery was provided of the crimped valve in the sheath.The crimped valve appears non-coaxially aligned on delivery system inside within the sheath suggesting increased contact with the sheath inner lumen and a torn liner.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to this 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 complaints for inability to advance through sheath, sheath liner strand, and sheath liner torn were confirmed based on the condition of the return device.A manufacturing non-conformance was not identified.Reviews of the dhr, lot history, and complaint history revealed no indication that a manufacturing non-conformance contributed to the event.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no note of abnormalities during device unpacking or preparation.As reported, 'the valve was not able to advance in the esheath due to high resistance'.Patient vessels were described as moderate calcification and tortuosity.Scratches were observed along the sheath shaft indicating that the device likely encountered calcification.A tortuous and calcified patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment in the advancement of the delivery system and create a constrained condition for the sheath during seam expansion.Non-coaxial alignment was noted in the imaging evaluation.As such, available information suggests that patient factors (tortuosity, calcification) may have contributed to the complaint event.No manufacturing non-conformances was identified during evaluation.A product risk assessment was (pra) previously performed per management discretion to assess the risks associated with high push force of the sapien 3 ultra valve with the commander delivery system and esheath configuration.In addition, a capa was previously initiated to capture further investigation and any possible corrective or preventative action activities.Non-coaxial alignment between the crimped valve and sheath was seen in the imagery provided which can lead to increased contact between the crimped valve and sheath inner lumen, likely causing the 'folding of the frames of the valve'.The bent valve struts likely caught on the liner tearing it.Additionally, to and tore it.Overcome the experienced resistance, excessive manipulation was likely applied.This excessive manipulation likely further caused the liner tears and strands.As such, available information suggests that procedural factors (bent valve strut, valve caught on liner, excessive manipulation, non-coaxial interaction) may have contributed to the complaint event.Since no edwards defect was identified, no corrective or preventative action nor pra 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: 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: 13261958
• MDR Text Key: 286054439
• Report Number: 2015691-2022-03405
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103191219
• UDI-Public: (01)00690103191219(17)230920(10)63994392
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

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 Expiration Date: 09/20/2023
• Device Model Number: 9610ES14
• Device Catalogue Number: N/A
• Device Lot Number: 63994392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2021
• 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: 86 YR
• Patient Weight: 83 KG