MAUDE Adverse Event Report: MEDTRONIC COREVALVE LLC COREVALVE EVOLUT R; PROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED

Model Number MEDTRONIC EVOLUT R 34-45

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2017

Event Type  malfunction  

Event Description

Tavr delivery device had a kinking in the sheath.Noted before placement into patient.Device was not retained.Another type of device utilized.Manufacturer response for transcatheter aortic valve delivery catheter system compression loading system, medtronic evolut r 34-45 (per site reporter): rep in on case.Device provided to rep.Unknown response.

• Brand Name: COREVALVE EVOLUT R
• Type of Device: PROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC COREVALVE LLC; 1851 east deere ave; santa ana CA 92705
• MDR Report Key: 7024558
• MDR Text Key: 91802622
• Report Number: 7024558
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/03/2017,11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MEDTRONIC EVOLUT R 34-45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1