MAUDE Adverse Event Report: MEDTRONIC, INC RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Model Number RSINT35018UX

Device Problem Failure to Deliver (2338)

Patient Problem No Information (3190)

Event Date 02/28/2014

Event Type  malfunction  

Event Description

The stent would not deliver through the guidewire.

• Brand Name: RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC, INC; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 3657308
• MDR Text Key: 4281257
• Report Number: 3657308
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: RSINT35018UX
• Device Catalogue Number: RSINT35018UX
• Device Lot Number: 0006868852
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR