MAUDE Adverse Event Report: MEDTRONIC COREVALVE SYSTEM; AORTIC VALVE

Catalog Number DCS-C4-18F-US

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/30/2015

Event Type  Injury  

Event Description

As the corevalve was being dislodged back into the arch of the aorta.At this time it was difficult to reload the valve into the descending aorta, so a decision was made to deploy the valve into the aortic aneurysm.A second corevalve was prepared and the delivery system was passed through the previous implanted aortic valve and the second valve was passed into the root of the aorta without any difficulty.

• Brand Name: COREVALVE SYSTEM
• Type of Device: AORTIC VALVE
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 5061576
• MDR Text Key: 25240889
• Report Number: MW5056014
• Device Sequence Number: 1
• Product Code: NPT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/01/2015

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 Catalogue Number: DCS-C4-18F-US
• Device Lot Number: 0007428273
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 96