MAUDE Adverse Event Report: MEDTRONIC IRELAND MEDTRONIC PRO DELIVERY CATHETER SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Catalog Number REF (240)D - EVPROP34US

Device Problem Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Upon exchanging 18fr dryseal sheath for evolut predelivery system, was unable to advance delivery system in left femoral artery, then tried to remove it and unable to remove it.Removable required surgical intervention.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC PRO DELIVERY CATHETER SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 12568900
• MDR Text Key: 274737372
• Report Number: MW5104342
• Device Sequence Number: 1
• Product Code: NPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2023
• Device Catalogue Number: REF (240)D - EVPROP34US
• Device Lot Number: (10)0010666632
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1