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

Model Number 914ESA

Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted upon completion.

Event Description

During the implantation of a 26mm sapien 3 ultra valve in the aortic position there was difficulty advancing the crimped valve on the commander past the tip of the esheath.With excessive force the valve was eventually advanced through the esheath and into the abdominal aorta.There was noticeable damage to the tip of the esheath on fluro.The implanter was not comfortable deploying the valve in fear that it was compromised getting it past the tip of the sheath.Attempts were made to retrieve the valve into the esheath in order to remove all as one unit but was unable to get the valve inside the esheath.There was an attempt to remove everything together with the valve butted up to the esheath but the valve got stuck in the femoral artery.Vascular surgery performed a cutdown on the artery to get the valve out.A second 14fr esheath was placed through a purse string in the artery placed by the surgeon.A 26mm sapien 3 valve successfully deployed without issue.It was hypothesized that perhaps the removal of the 22 vida bav damaged the tip.As reported by the fcs, we just found out that this patient was brought to ct and was found to have a hemorrhagic stroke and has deceased.Upon engineering review of images, it was noticed that the esheath had a tear at the distal tip.

Manufacturer Narrative

The device was not returned.An image review was performed on images provided and the following was observed: the sheath distal tip was shown to be torn but still attached to the shaft, liner fully expanded as designed and distal tip appears not have opened along the axial score line as designed.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other similar complaints.A review of edwards lifesciences risk management documentation was performed for this case and revealed no evidence of product non-conformance or labeling/ifu inadequacies were identified in the evaluation.The complaint events were confirmed per evaluation of the returned device imagery.However, no manufacturing nonconformance was identified during evaluation.Review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of manufacturing mitigation 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.Per the complaint description, "with excessive force the valve was eventually advanced through the esheath and into the abdominal aorta.There was noticeable damage to the tip of the esheath on fluro".Per evaluation of the provided imagery, the sheath distal tip was observed to be torn along the distal edge of the sheath.The failure mode is likely related to improper expansion of the sheath tip during thv advancement.The failure mode is characteristic of sheath tip tear events identified in a product risk assessment (pra).While a definitive 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 resistance experienced at the sheath distal tip during delivery system advancement and the distal tip tear.However, a definitive root cause is unable to be determined at this time.A pra has been previously initiated to document investigation and assess associated risks for the issue.No further actions are required at this time.

Manufacturer Narrative

This supplemental is one of two reports being submitted for this case.Please reference manufacturer report number 2015691-2022-03645.Additional information was provided through voluntary mw5106929.On passing the tavr prosthesis through the esheath, the prosthesis abruptly met stiff resistance at the tip of the esheath (unclear mechanism; tip of esheath was found to be split/frayed upon removal).This resulted in the extra stiff coming out of the left ventricle.The tavr prosthesis did go through the esheath, but it was decided to remove sheath and valve en block because passing back into the left ventricle with wire would be highly challenging especially in light of this patient's anatomy.This was followed by successful tavr and surgical closure of incision in the right common femoral artery and external iliac artery.Angiogram showed good flow down right iliofemoral system without significant stenosis and no extravasation.Perclose achieved good hemostasis of the left femoral artery.The investigation is still ongoing.

• 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: 13358664
• MDR Text Key: 284976031
• Report Number: 2015691-2022-03644
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103193985
• UDI-Public: (01)00690103193985(17)230823(10)63946937
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2023
• Device Model Number: 914ESA
• Device Catalogue Number: 914ESA
• Device Lot Number: 63946937
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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 Sex: Male