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

Model Number 914ESJ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rupture (2208)

Event Date 06/06/2022

Event Type  Death  

Manufacturer Narrative

Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential risks or adverse events associated with the overall thv procedure and may require intervention.The thv physician training manuals instruct on procedural considerations for sheath insertion with regards to proper screening critical to reducing vascular complications.The training manual instructs the operator on proper sheath insertion and withdrawal techniques, including pre-dilating the vessel with the edwards dilators, as needed.It also notes that calcification may reduce lumen diameter and limit or prevent the transfemoral passage of the devices.Per the instructions for use (ifu), artery rupture and death are a potential adverse events associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.The root cause of the event remains indeterminable.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 this adverse event is not required at this time.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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

Event Description

Edwards received notification from our affiliate in (b)(6).As reported, the patient underwent a trans-subclavian transcatheter aortic valve replacement (tavr) procedure with a 23mm sapien 3 valve was performed per manual.14 fr esheath was inserted via left subclavian artery.There was no abnormality during sheath insertion nor resistance during sheath insertion.Post implant, there was no abnormality in the subclavian artery by echography, the patient left the operating room.The patient complained backache and suddenly changed overnight.Percutaneous cardiopulmonary support (pcps) was implemented.Endovascular treatment (evt) was performed emergency.However, the patient did not recover, and then passed away on postoperative day (pod) 3.Per the operator, the causal relation of the event with both the device and the procedure was determined as ''unknown''.The cause of death was reported as left subclavian artery rupture.

• 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: 14918895
• MDR Text Key: 295272956
• Report Number: 2015691-2022-06626
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103194838
• UDI-Public: (01)00690103194838(17)231124(10)64120997
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2023
• Device Model Number: 914ESJ
• Device Catalogue Number: N/A
• Device Lot Number: 64120997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 45 KG