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

Model Number 914ESPA

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Great Vessel Perforation (2152)

Event Date 03/10/2022

Event Type  Death  

Event Description

As reported, during the procedure with a 23mm sapien in the aortic position via transfemoral approach a16fr dilator was inserted into the esheath plus to pre-dilate, then the 14fr esheath plus was inserted into the patient without difficulty.A balloon aortic valvuloplasty (bav) was performed using a non-edwards bav balloon.Upon removal of the non-edwards bav balloon, there was mild resistance noted within the esheath plus.The delivery system and valve were inserted into the same sheath.The operator noted advancing with minimal issue, but could see the nosecone on screen was not moving and the valve and delivery system was completely outside of the sheath through a tear in the sheath shaft.The nosecone of the delivery system never exited the distal end of the sheath.The aorta ruptured due to the continued advancement of the delivery system.Because of the tear in the esheath plus, the delivery system could not be successfully pulled into the sheath as the valve was hanging on some portion of the tear.It was suspected that the sheath tore during delivery system insertion or possibly during removal of the bav balloon.An aortic occlusion balloon was inserted via contralateral common femoral artery (cfa) access.Chest compression was performed.The patient expired.

Manufacturer Narrative

Investigation is ongoing.Device remains in patient.

Manufacturer Narrative

H6 updated.The device was not returned for evaluation therefore, a no visual inspection, functional testing, dimensional testing was performed.Imagery was provided by the site and revealed the following: moderate calcification present in patients access vessel and mild tortuosity present in patients access vessel.The device history record dhr were reviewed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review of the related work order was performed and revealed no other complaints relating to the complaint codes below.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.The following instructions were reviewed; esheath plus and commander delivery system ifu, preparation and procedural manual.Edwards has provided the guidelines or instructions to physicians in the ifu and device preparation and procedural training manuals.No ifu/training deficiencies were identified.The complaints for sheath damaged, inability to advance through sheath, and withdrawal difficulty through esheath were unable to be confirmed, therefore, a complaint history review is not required.A review of edwards lifesciences risk management documentation was performed for this case.Current risk mitigations include design and manufacturing controls, ifu warnings and cautions, and physician training on how to insert delivery system into sheath.No evidence of product nonconformances or labeling/ifu inadequacies were identified in the evaluation.This case utilized a nonedwards bav interacting with the edwards esheath.Edwards risk management system does not conduct risk assessments for events associated with nonew devices.While a definitive root cause could not be determined, review of the complaint file suggests that patient factors may have contributed to the complaint event.As such, the review of the risk management file is complete, and no further action is required at this time.The complaints for sheath damaged, inability to advance through sheath, and withdrawal difficulty through nonew sheath were unable to be confirmed without the returned device.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing nonconformance was unable to be determined.Review of the dhr and lot history did not provide any indication that a manufacturing nonconformance would have contributed to the complaint event.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, there was no report of any issues with the sheath during device unpacking or preparation.As reported, upon removal of the bav balloon, there was mild resistance noted and the operators panned down to see what appeared to be the valve and delivery system completely outside of the sheath, through a tear.Because of this tear, the delivery system could not be successfully pulled into the sheath as the valve was hanging on some portion of the tear.Additionally, it was reported that the 16fr dilator was inserted into the sheath to presplit.Per the training manual, advance the expansion tool into sheath housing until it reaches the sheath hub.As the dilator was used to preexpand the sheath and the dilator length is longer than the expansion tool, the sheath liner seam likely was lifted/expanded a longer length along the sheath shaft.This could lead to increased exposure of the liner to contact with vessel characteristics.Returned patient imagery and case notes report the patient had mild tortuosity and moderate calcification.Calcification can damage the exposed portion of the sheath liner and lead to immediate cutting/tear or could weaken the liner.A weakened liner can tear during retrieval of the bav or advancement of the delivery system.Tortuosity present in the patients access vessels may have also created non coaxial alignment of the bav and sheath distal tip upon reentry into the sheath.The misalignment potentially could have led to the balloon to catch onto the sheath, while any potential excess device manipulation to overcome the withdrawal difficulty could lead to the reported sheath damage.In addition, it is possible that the sheath was damaged during delivery system advancement compounded by the same vessel characteristics.However, without the returned device or device imagery, the extent and location of the damage is unknown.As such, available information suggests that patient tortuosity, calcification and/or procedural improper sheath preparation, non edwards device interaction, excessive manipulation factors may have contributed to the reported complaint events.However, a definitive root cause is unable to be determined at this time.As reported, the doctor noted he was advancing with minimal issue, but they could see the nosecone on screen was not moving.They panned down to see what appeared to be the valve and delivery system completely outside of the sheath through a tear.The damage noted on the sheath prevented the delivery system from being advanced further into the sheath.It is also possible that vessel tortuosity may have also created noncoaxial alignment between the delivery system and the sheath during advancement.As such, available information suggests that patient tortuosity and/or procedural damaged sheath factors may have contributed to the reported complaint events.However, as no procedural or devicerelated imagery was provided, a definitive root cause is unable to be determined at this time.Since no product nonconformance was confirmed, a product risk assessment escalation is not required.Since no edwards defect was identified to have contributed to the complaint events, no corrective/preventative actions are required.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.No corrective or preventative actions are required.

• Brand Name: EDWARDS ESHEATH PLUS
• 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: 13972399
• MDR Text Key: 288349726
• Report Number: 2015691-2022-04733
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)231103(11)2111032164076035
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2023
• Device Model Number: 914ESPA
• Device Lot Number: 64076035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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 Outcome(s): Death
• Patient Sex: Male