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

Model Number 914ESPJ

Device Problems Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problem Perforation of Vessels (2135)

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

During a tavr procedure using a 23mm sapien 3 ultra resilia valve, when the delivery system was inserted into the e-sheath+, there was more resistance than usual, and it was difficult to advance.The delivery system (ds) was pushed but it advanced slowly.The implanter reported that it was "strange" because there was strong resistance from the delivery system insertion into the sheath until the delivery system came out the sheath.After that, the s3 ur implantation was performed as usual.The implanter also reported that there was a little more resistance than usual when the delivery system was removed from the sheath.After removing the esheath, the distal tip torn was observed.After the procedure, iliac artery rupture was reported (exact occurrence date was unknown.It was the same day of tavr procedure or pod 1), and it was repaired with stent graft.According to the implanter, it was not known whether the iliac rupture occurred by resistance during delivery system insertion, or during removing the sheath.The timing of the rupture was unknown.There was no resistance when inserting and removing the esheath.Per report, the patient's minimal access vessel diameter was maintained (6.0mm) and the degree of calcification and tortuosity of access vessel was mild.The devices were prepared as instructed in the training manual and no abnormalities were observed prior to use.The devices will be returned for evaluation.

Manufacturer Narrative

Correction to h6; component code, type of investigation, investigation findings, investigation conclusion.The 14 fr esheath plus was returned to edwards lifesciences for evaluation and confirmed the reported event.A visual examination found that the sheath shaft was slightly curved, liner was fully expanded, as designed, sheath distal tip was torn radially with scratches along the axial scoreline, the tip did not open along the axial scoreline and the liner at the tip was partially delaminated on sides of the seam.Functional and dimensional testing was unable to be performed.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed other complaints relating to the complaint code.The esheath+ ifu, commander delivery system ifu, and device preparation manual instructions and procedural training manual for use (ifu) were reviewed.Based on the review, no ifu/training deficiencies were identified.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 reported events of distal tip torn and resistance between system components was confirmed per evaluation of the returned device.However, no manufacturing nonconformance was identified during the evaluation.A review of the dhr, lot history, and complaint 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.The physician also reported that there was a little more resistance than usual when the delivery system was removed from the sheath.After removing the esheath, the distal tip torn was observed.Per evaluation of the returned device, the sheath distal tip was observed to be torn radially along the distal edge of the liner.While a conclusive 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.Additionally, as reported, "the degree of calcification and tortuosity of access vessel was mild".Per the training manual, "push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification".Tortuosity can lead to non-coaxial alignment between the crimped valve and the sheath, which may lead to the valve struts to catch onto the sheath distal tip, tearing the tip.Additionally, calcification can scratch the sheath distal tip and disrupt tip opening, potentially contributing to the tip being torn.The physician also reported that there was a little more resistance than usual when the delivery system was removed from the sheath.Additionally, as reported, "the degree of calcification and tortuosity of access vessel was mild".Per evaluation of the returned device, the sheath shaft was curved, suggesting the 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." tortuosity and calcification can create sub-optimal angles for delivery system advancement, that can lead to non-coaxial alignment between the devices, requiring a high push force to navigate.Calcification can create a constrained condition for delivery system advancement, further contributing to resistance.In the case of resistance issues, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.In the case of a torn distal tip, the failure mode may be related to improper expansion of the sheath tip during thv advancement, and/or patient factors (tortuosity, calcification) may have contributed to the complaint events.However, a definitive root cause is unable to be determined at this time.The failure mode is characteristic of sheath tip tear events that were captured in a previous risk assessment.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 lifesciences; 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: 18067403
• MDR Text Key: 327313270
• Report Number: 2015691-2023-17254
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103217360
• UDI-Public: (01)00690103217360(17)241205(10)64766659
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPJ
• Device Lot Number: 64766659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female