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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-10-7-40-135
Device Problem Shelf Life Exceeded (1567)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2016
Event Type  malfunction  
Event Description
The physician implanted a protege rx carotid stent in the carotid artery.The device was inspected and prepped prior to use with no issues noted however the stent was used approximately 94 days past its expiration date (11 march 2016).No patient complications reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key5811574
MDR Text Key50075695
Report Number2183870-2016-00538
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P060001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/11/2016
Device Catalogue NumberSEPX-10-7-40-135
Device Lot Number9881925
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2016
Date Device Manufactured03/12/2014
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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