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

Model Number 914ESPA

Device Problem Difficult to Advance (2920)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 10/04/2022

Event Type  Injury  

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral transcatheter aortic valve replacement (tavr) procedure of a 26mm sapien 3 ultra valve, the delivery system with crimped valve was unable to be fully advanced through the 14fr esheath+.It was noted that there was also difficulty introducing the esheath+ into the patient.The procedure was aborted for patient safety.There was concern regarding the access site with a possible hematoma.The patient ended up developing a hematoma which required further vascular interventions.The hematoma was observed to be above the common femoral artery in an area of tortuosity as extravasation was noted.The patient was stented and was in stable condition.

Manufacturer Narrative

The investigation is ongoing.Device not available for return.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and includes additional information based on investigation.The following sections of this report have been corrected/updated: h6 (type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data).The device was not returned to edwards lifesciences for evaluation.As a result, no visual inspection, functional testing, or dimensional analysis could be performed.Imagery of the patient's anatomy was provided.Review of the imagery revealed presence of an undersized vessel.In addition, calcification and tortuosity were present in the patient's access vessels.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 also performed and revealed no other events relating to the reported event.During manufacturing, the device undergoes multiple 100% inspections.In addition, the work order underwent functional product verification testing on a sampling basis as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported event.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the esheath+, delivery system and valve usage.Based on the review of the ifu/training manuals, no 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 events for inability to advance delivery system with valve through the esheath+ and difficulty introducing the esheath+ were unable to be confirmed without the returned device or procedural imagery.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the events.A review of manufacturing mitigations supports that the esheath+ has proper inspections in place to detect issues related to the events.A review of the ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the esheath+ during device unpacking or preparation.As reported "during a transfemoral transcatheter aortic valve replacement (tavr) procedure of a 26mm sapien 3 ultra valve, the delivery system with crimped valve was unable to be fully advanced through the 14fr esheath+.It was noted that there was also difficulty introducing the esheath+ into the patient." a review of the imagery provided of the patient's anatomy revealed the presence of tortuosity, calcification, and undersized vessels within the patient's vasculature.Per the ifu/training manual, "push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity, and degree of calcification." calcification can present a barrier in introducing the sheath as well as reducing the vessel lumen diameter.Undersized vessels and calcification can create a constrained effect on the sheath, increasing resistance during sheath insertion and delivery system advancement.Tortuosity can create sub-optimal angles that can lead to non-axial alignment and advancement in sheath insertion and delivery system advancement.In this case, available information suggests that patient factors (tortuosity, calcification, and undersized vessels) may have contributed to the reported events.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.A previous corrective and preventive action (capa) was initiated to improve activities regarding insertion of the delivery system with valve through the sheath resulting in high push force.Since the event occurred after correction actions were implemented, a product risk assessment (pra) was performed and found the control limits have not been exceeded.Therefore, no further 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: 15674984
• MDR Text Key: 302435871
• Report Number: 2015691-2022-08842
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240705(11)2207062164466742
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPA
• Device Catalogue Number: 914ESPA
• Device Lot Number: 64466742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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 Sex: Male