MAUDE Adverse Event Report: MEDTRONIC COREVALVE LLC MEDTRONIC ENVEO R DELIVERY CATHETER SYSTEM

Lot Number 0008653239

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 09/18/2017

Event Type  Injury  

Event Description

During a tavr procedure the valve delivery system malfunctioned and the valve along with the delivery section of the device separated from the shaft.A cut down was performed on the left femoral artery.The valve delivery system was removed.Due to significant damage to the left femoral artery the procedure was aborted.The left femoral artery was repaired.The valve delivery system separated from the shaft.There was significant damage to the left femoral artery which was repaired.The tavr procedure had to be aborted.Date the implant was put in: procedure aborted.

• Brand Name: MEDTRONIC ENVEO R DELIVERY CATHETER SYSTEM
• Type of Device: MEDTRONIC ENVEO R DELIVERY CATHETER SYSTEM
• Manufacturer (Section D): MEDTRONIC COREVALVE LLC
• MDR Report Key: 6916178
• MDR Text Key: 88820870
• Report Number: MW5072624
• Device Sequence Number: 2
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/20/2017
• 2 Devices were Involved in the Event: 1 2

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: 05/29/2018
• Device Lot Number: 0008653239
• Other Device ID Number: RED # ENVEOR-N-US
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 130