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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN EVERFLEX+ SELF-EXPANDING PERIPHERAL STENT SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY
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COVIDIEN EVERFLEX+ SELF-EXPANDING PERIPHERAL STENT SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number EFV35-06020080
Device Problem Material Separation (1562)
Patient Problem Vascular Dissection (3160)
Event Date 10/29/2015
Event Type  Injury  
Manufacturer Narrative
Additional information has been requested.Should it become available, a supplemental report will be submitted.(b)(4).
 
Event Description
This procedure was performed in (b)(6).After expanding the everflex + stent in the distal part of the superficial femoral artery the physician reported that the stent broke apart.An open operation was performed to remove the damaged stent and to reconstruct the damaged artery.
 
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Brand Name
EVERFLEX+ SELF-EXPANDING PERIPHERAL STENT SYSTEM STANDARD
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane n
plymouth MN 55442
Manufacturer Contact
mary haufek
4600 nathan lane n
plymouth, MN 55442
7633987000
MDR Report Key5243181
MDR Text Key31908291
Report Number2183870-2015-07553
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P110023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 10/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/08/2016
Device Model NumberEFV35-06020080
Device Catalogue NumberEFV35-06020080
Device Lot Number9840005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/29/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/09/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age00070 YR
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