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

Model Number 914ESPA

Device Problems Failure to Advance (2524); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The device is not returning.

Event Description

As reported by a field clinical specialist (fcs), during the procedure of a 23 mm sapien 3 ultra valve in the aortic valve in a surgical valve via transfemoral approach.The first esheath was not able to track up the aorta and had noticeably separated from the introducer at the tip on fluoroscopy.A new sheath was prepared and the guide wire was replaced, the sheath was tracked without issue.During deployment, the team was unable to cross the surgical valve.After multiple tries and techniques the patient went into ventricular fibrillation (v-fib) arrest.Cpr, multiple shocks and a left main stent deployment were performed.The patient eventually regained a rhythm and blood pressure.It was decided to abort the procedure at this time.The patient is stable and will be re-evaluated for a open heart surgery.Per the fcs response, during fluoroscopy, it was noted that the first esheath's tip was getting caught on the calcium and distal tip torn was noted.There was no allegation that the ew device cause or contributed to the inability to cross the surgical valve.Left main stent was deployed because no flow was noted down the left main.The stent was already parked in the lad for protection and was planned to be deployed after we implanted the valve and "snorkled" into the aorta.

Manufacturer Narrative

A supplemental mdr is being submitted for correction.The following sections of this report have been updated: corrected b.5 event description.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-07410.This complaint is in reference to 2022-13435-01.The investigation is still ongoing.

Event Description

As reported by a field clinical specialist (fcs), during the procedure of a 23 mm sapien 3 ultra valve in the aortic valve in a surgical valve via transfemoral approach.The first esheath was not able to track up the aorta and had noticeably separated from the introducer at the tip on fluoroscopy.A new sheath was prepared and the guide wire was replaced, the sheath was tracked without issue.During deployment, the team was unable to cross the surgical valve.After multiple tries and techniques the patient went into ventricular fibrillation (v-fib) arrest.Cpr, multiple shocks and a left main stent deployment were performed.The patient eventually regained a rhythm and blood pressure.It was decided to abort the procedure at this time.The patient is stable and will be re-evaluated for a open heart surgery.Per the fcs response, during fluoroscopy, it was noted that the first esheath's tip was getting caught on the calcium and distal tip torn was noted.Left main stent was deployed because no flow was noted down the left main.The stent was already parked in the lad for protection and was planned to be deployed after we implanted the valve and "snorkled" into the aorta.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was not provided for review.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaints were unable to be confirmed as there was no returned device of sheath imagery.With no returned device, engineering was unable to be perform additional visual inspection or functional/dimensional testing.Therefore, a manufacturing non-conformance could not be identified.Reviews of the dhr and lot history showed no indication a manufacturing non-conformance contributed to the event.No ifu/training manual deficiencies were identified.As reported ''the first esheath was not able to track up the aorta and had noticeably separated from the introducer at the tip on fluoroscopy.'' furthermore, follow-up information revealed that ''the first esheath's tip was getting caught on the calcium and distal tip torn was noted.'' per ifu/trainings ''push force can vary due to angle of access and insertion, vessel diameter, tortuosity, and degree of calcification.'' calcification can reduce the vessel lumen diameter and can create a constrained condition resulting in difficulty during the advancement of the esheath+.Sharp calcified nodules can create obstacles for the esheath+ advancement.With the inability to advance, excessive manipulation of the sheath near sharp calcified nodules may have led to the distal tip to catch onto a nodule and tear, as reported.As such, available information suggests that patient (calcification) and procedural (excessive manipulation) factors may have contributed to this complaint event.However, a definitive root cause is unable to be determined at this time.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• 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: 15250084
• MDR Text Key: 302059342
• Report Number: 2015691-2022-07391
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240404(11)2204052164307748
• 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,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPA
• Device Catalogue Number: 914ESPA
• Device Lot Number: 64307748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2022
• 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 Sex: Male