Stent, Superficial Femoral Artery

Device Code: 1049

Product Code(s): NIP

Definition: Stent, Superficial Femoral Artery -- A Metal Scaffold Placed Via A Delivery Catheter Into The Superficial Femoral Artery Artery To Maintain The Lumen

Device Classification Information

Device Type ID1049
Device NameStent, Superficial Femoral Artery
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Peripheral Interventional Devices Branch (PIDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeNIP
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1049
DeviceStent, Superficial Femoral Artery
Product CodeNIP
FDA Device ClassificationClass 3 Medical Device
Device Problems
Stent
 377
Activation, Positioning Or Separation Problem
 301
Fracture
 295
Adverse Event Without Identified Device Or Use Problem
 215
Positioning Failure
177
Occlusion Within Device
 164
Difficult To Remove
137
Break
 131
Catheter
 103
Stretched
 93
Premature Activation
92
Entrapment Of Device
 84
Bent
 80
Material Deformation
 74
Material Twisted / Bent
 65
Material Torqued
 62
Difficult Or Delayed Positioning
 61
Device Operates Differently Than Expected
 58
Detachment Of Device Component
 53
Failure To Advance
 52
Material Separation
 40
Activation Failure Including Expansion Failures
39
Detachment Of Device Or Device Component
 35
Improper Or Incorrect Procedure Or Method
 33
Obstruction Of Flow
 31
Misfire
26
Difficult Or Delayed Activation
23
Difficult To Advance
 21
Positioning Problem
 19
Kinked
 17
Retraction Problem
 17
Malposition Of Device
16
Device Deployer
 14
Device Dislodged Or Dislocated
 11
Shaft
 11
Insufficient Information
 11
Mechanical Jam
 11
Leak / Splash
 10
Partial Blockage
 10
Tip
 10
Migration Or Expulsion Of Device
10
Torn Material
 9
Mechanical Problem
 9
Inaccurate Delivery
8
Physical Resistance / Sticking
 8
Device Damaged By Another Device
 8
Migration
 8
Delivered As Unsterile Product
 7
Component Missing
6
Sticking
 6
Difficult To Position
 6
Device Expiration Issue
 5
Device Damaged Prior To Use
5
Loss Of Or Failure To Bond
 5
Physical Resistance
 5
Patient-Device Incompatibility
 5
Tear, Rip Or Hole In Device Packaging
 4
Difficult To Insert
 4
Device Markings / Labelling Problem
 4
Dent In Material
 4
Inadequacy Of Device Shape And/or Size
 4
Device-Device Incompatibility
 4
Defective Device
 3
Defective Component
 3
Failure To Fire
3
Compatibility Problem
 2
Material Integrity Problem
 2
Contamination During Use
 2
Product Quality Problem
 2
Device Inoperable
 2
Use Of Device Problem
 2
Deformation Due To Compressive Stress
2
Wire
 2
Labelling, Instructions For Use Or Training Problem
 2
Improper Flow Or Infusion
 2
Peeled / Delaminated
 2
Therapy Delivered To Incorrect Body Area
2
Off-Label Use
 2
Material Too Rigid Or Stiff
 1
Hole In Material
 1
Device Packaging Compromised
 1
Inadequate Or Insufficient Training
 1
Separation Failure
1
Complete Blockage
 1
Device Misassembled During Manufacturing / Shipping
 1
Device Contamination With Chemical Or Other Material
 1
Noise, Audible
 1
Delivery System Failure
 1
Material Distortion
 1
Failure To Disconnect
 1
Scratched Material
 1
Firing Problem
 1
Contamination / Decontamination Problem
1
Unintended System Motion
 1
Delamination
 1
Unintended Ejection
1
Appropriate Term/Code Not Available
 1
Material Split, Cut Or Torn
 1
Physical Property Issue
 1
Guidewire
 1
Total Device Problems 3270
Recalls
Manufacturer Recall Class Date Posted
1
Boston Scientific Corporation
 II Feb-22-2018
2
Ev3, Inc.
 II Jun-23-2016
3
Medtronic Inc.
 II Nov-29-2017
4
Terumo Medical Corp
 II Nov-29-2016
TPLC Last Update: 2019-04-02 19:47:27
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.