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 Vascular Dissection (3160)

Event Date 05/26/2022

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures, annular tear, or rupture are known potential adverse events associated with the overall thv procedure and may require intervention.Ascending aortic dissection may occur when multiple attempts are made to cross the stenotic native valve, and/or when excessive force is used.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).The thv training manuals guide to facilitate safe crossing of the native valve, including camera projections, handling during advancement, and troubleshooting techniques if difficulty is encountered.As stated, excessive force should not be used when the device has difficulty crossing the stenotic valve.Adding tension to the wire, pulling back the system to re-orient the valve, as needed, and torquing the flex catheter may help solve the problem.Per the instructions for use (ifu), vascular dissection is a potential adverse event 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.Investigation results are inconclusive, as the exact cause is unknown.However, the event could be related to the mechanism described above.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

As reported through the japanese tavi registry reporting system, the patient underwent a transfemoral transcatheter aortic valve replacement (tavr) and received a 23 mm sapien 3 valve in the native aortic position.Dissection was found in the common iliac artery (cia).As a treatment, percutaneous transluminal angioplasty (pta) was performed and a stent was placed.As of the same day, the outcome was improving.

Manufacturer Narrative

During an administrative review it was noted that the field for component code (h6) was incorrect from the initial submitted mdr.The date of this report nov 15, 2022.As such this mdr is being submitted as a corrected supplemental.

• 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: 15693031
• MDR Text Key: 302682239
• Report Number: 2015691-2022-08884
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103194838
• UDI-Public: (01)00690103194838(17)240203(10)64223810
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2024
• Device Model Number: 914ESJ
• Device Lot Number: 64223810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female