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U.S. Department of Health and Human Services

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

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MEDTRONIC, INC INTEGRITY CORONARY STENT SYSTEM STENT, CORONARY Back to Search Results
Catalog Number INT30030UX
Device Problems Stent (515); 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.

 
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Brand NameINTEGRITY CORONARY STENT SYSTEM
Type of DeviceSTENT, CORONARY
Manufacturer (Section D)
MEDTRONIC, INC
3576 unocal pl.
santa rosa CA 95403
MDR Report Key5301606
MDR Text Key33597210
Report Number5301606
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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 Received12/16/2015
Is This An Adverse Event Report? Yes
Device Operator
Device EXPIRATION Date03/18/2017
Device Catalogue NumberINT30030UX
Device LOT Number0007506412
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/09/2015
Event Location Hospital
Date Report TO Manufacturer12/09/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/16/2015 Patient Sequence Number: 1
Treatment
CARDIAC DRUGS
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