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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG; STENT, ILIAC
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COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG; STENT, ILIAC Back to Search Results
Catalog Number PRB35-06-100-120
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 11/09/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A protege everflex self-expanding stent was implanted in a calcified lesion in the right distal sfa in (b)(6) 2017.The artery had moderate tortuosity.During a follow-up appointment, it was discovered that the stent had fractured.It was reported that no part of the stent had migrated.Another stent was placed inside the fractured stent following a pre-dilation with a 5x100 pre-dilation balloon.No patient injury was reported.
 
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Brand Name
PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
Common Device Name
STENT, ILIAC
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
MDR Report Key7114223
Report Number2183870-2017-00568
Device Sequence Number11231274
Product Code NIO
UDI-Device Identifier00821684069226
UDI-Public00821684069226
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
P110023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/15/2019
Device Catalogue NumberPRB35-06-100-120
Device Lot NumberA228568
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/14/2017
Initial Report FDA Received Date12/13/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age63 YR
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