System, Endovascular Graft, Aortic Aneurysm Treatment

Device Code: 1029

Product Code(s): MIH

Device Classification Information

• Device Type ID: 1029
• Device Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Vascular Surgery Devices Branch (VSDB)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: MIH
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 3-99 AAMI TIR 42:2010
  Evaluation Of Particulates Associated With Vascular Medical Devices
• 3-104 ASTM F2914-12
  Standard Guide For Identification Of Shelf-life Test Attributes For Endovascular Devices
• 3-137 ASTM F3036-13
  Standard Guide For Testing Absorbable Stents
• 3-138 ASTM F2942-13
  Standard Guide For The In Vitro Axial, Bending, And Rotational Durability Test Of Vascular Stents
• 3-142 ISO /TS 17137 First Edition 2014-05-15
  Cardiovascular Implants And Extracorporeal Systems - Cardiovascular Absorbable Implants.
• 3-149 ISO 25539-1 Second Edition 2017-02
  Cardiovascular Implants - Endovascular Devices - Part 1: Endovascular Prostheses
• 3-157 AAMI ANSI ISO 25539-1: 2017
  Cardiovascular Implants - Endovascular Devices - Part 1: Endovascular Prostheses

Total Product Life Cycle

• Device Type ID: 1029
• Device: System, Endovascular Graft, Aortic Aneurysm Treatment
• Product Code: MIH
• FDA Device Classification: Class 3 Medical Device

Device Problems
Leak / Splash	5611
Adverse Event Without Identified Device Or Use Problem	1744
Failure To Adhere Or Bond	1245
Migration Or Expulsion Of Device	803
Occlusion Within Device	779
Hole In Material	660
Malposition Of Device	520
Material Integrity Problem	317
Activation, Positioning Or Separation Problem	299
Patient-Device Incompatibility	264
Detachment Of Device Component	227
Material Puncture / Hole	220
Insufficient Information	214
Loss Of Or Failure To Bond	207
Unintended Movement	206
Break	189
Stretched	173
Difficult To Remove	157
Improper Or Incorrect Procedure Or Method	140
Positioning Failure	127
Off-Label Use	124
Failure To Advance	119
Kinked	118
Appropriate Term/Code Not Available	110
Difficult Or Delayed Positioning	108
Difficult To Position	104
Fracture	103
Partial Blockage	100
Material Deformation	99
Detachment Of Device Or Device Component	93
Material Separation	92
Fluid Leak	90
Obstruction Of Flow	86
Device Damaged By Another Device	84
Use Of Device Problem	76
Device Operates Differently Than Expected	73
Collapse	65
Difficult To Advance	62
Device Dislodged Or Dislocated	59
Deformation Due To Compressive Stress	55
Difficult To Insert	53
Folded	52
Inadequacy Of Device Shape And/or Size	43
Torn Material	41
Migration	35
Positioning Problem	32
Inability To Irrigate	28
Patient Device Interaction Problem	28
Separation Failure	22
Defective Device	19
Failure To Unfold Or Unwrap	17
Product Quality Problem	17
Material Twisted / Bent	17
Bent	17
Retraction Problem	17
Material Frayed	16
Human-Device Interface Problem	16
Premature Activation	16
Material Rupture	16
Disconnection	14
Device Markings / Labelling Problem	14
Activation Failure Including Expansion Failures	14
No Apparent Adverse Event	13
Physical Resistance	13
Compatibility Problem	13
Entrapment Of Device	13
Complete Blockage	13
Other (for Use When An Appropriate Device Code Cannot Be Identified)	12
Device Expiration Issue	11
Device Slipped	11
Material Fragmentation	11
Catheter	11
Stent	11
Material Invagination	9
Burst Container Or Vessel	9
Infusion Or Flow Problem	9
Defective Component	8
Component Or Accessory Incompatibility	8
Separation Problem	8
Difficult Or Delayed Activation	8
Packaging Problem	7
Microbial Contamination Of Device	7
Device-Device Incompatibility	7
Filling Problem	6
Dissection	6
Biocompatibility	6
Explanted	6
Delamination	6
Contamination During Use	5
Valve	5
Device Contamination With Chemical Or Other Material	5
Mechanical Jam	5
Sticking	4
Unintended Collision	4
Pressure Problem	4
Dent In Material	4
Flaked	4
Rupture, Cause Unknown	4
Manufacturing, Packaging Or Shipping Problem	4
Mechanical Problem	4
Total Device Problems	16760

Recalls
Manufacturer		Recall Class	Date Posted
1	Bard Peripheral Vascular Inc	II	Nov-05-2015
2	Cook Medical Incorporated	I	Aug-10-2017
3	Endologix	I	Oct-03-2018
4	Endologix	II	Jan-19-2017
5	Endologix	II	Jan-19-2017
6	Endologix	II	Jan-19-2017
7	Endologix	II	Jan-19-2017
8	Endologix	II	Jan-18-2017
9	Endologix	II	Jan-18-2017
10	Endologix	II	Jan-18-2017
11	Medtronic Vascular, Inc.	II	Mar-15-2017
12	Trivascular, Inc	I	Nov-03-2014
13	Trivascular, Inc	II	Mar-26-2014
14	W L Gore & Associates, Inc.	II	Oct-25-2017

TPLC Last Update: 2019-04-02 19:47:00