MAUDE Adverse Event Report: EDWARDS LIFE SCIENCES LLC. EDWARDS ESHEATH+ INTRODUCER SET; INTRODUCER, CATHETER

Lot Number 64199185

Device Problems Malposition of Device (2616); Material Protrusion/Extrusion (2979); Material Split, Cut or Torn (4008)

Patient Problem Vascular Dissection (3160)

Event Date 04/05/2022

Event Type  Injury  

Event Description

During tavr procedure, while attempting to place and deploy valve, the catheter delivery system became lodged in peripheral vessel.Physicians were able to remove delivery system and upon assessment noticed the sheath was split and the valve was protruding through shaft of catheter of delivery system.The femoral artery dissected requiring consult with vascular service and repair with stenting.Fda safety report id# (b)(4).

• Brand Name: EDWARDS ESHEATH+ INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFE SCIENCES LLC.; irvine CA 92614
• MDR Report Key: 14085187
• MDR Text Key: 289224542
• Report Number: MW5108917
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2024
• Device Lot Number: 64199185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: White