MAUDE Adverse Event Report: MEDTRONIC, INC INTEGRITY CORONARY STENT SYSTEM; STENT, CORONARY

Catalog Number INT30030UX

Device Problems Mechanical Problem (1384); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2015

Event Type  malfunction  

Event Description

When the physician was getting ready to deploy the stent, physician felt the stent and could feel the strut of the stent was defective or had a burr on it.Stent never went into patient.

• Brand Name: INTEGRITY CORONARY STENT SYSTEM
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): MEDTRONIC, INC; 3576 unocal pl.; santa rosa CA 95403
• MDR Report Key: 5301606
• MDR Text Key: 33597210
• Report Number: 5301606
• Device Sequence Number: 1
• Product Code: NIQ
• 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: Other
• Type of Report: Initial
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/18/2017
• Device Catalogue Number: INT30030UX
• Device Lot Number: 0007506412
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS