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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID
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COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID Back to Search Results
Catalog Number SEPX-8-6-40-135
Device Problem Device Expiration Issue (1216)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/13/2017
Event Type  malfunction  
Event Description
The physician used one protege gps stent to treat a carotid artery lesion.The device was removed from the packaging and inspected with no issues noted.The device was deployed successfully with no problems.It was reported that the device had passed its expiration date prior to use.No patient injury was reported.
 
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Brand Name
PROTEGE RX CAROTID STENT SYSTEM
Type of Device
STENT, CAROTID
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6610081
MDR Text Key76628580
Report Number2183870-2017-00236
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
P060001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 05/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/10/2017
Device Catalogue NumberSEPX-8-6-40-135
Device Lot NumberA071477
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/11/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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