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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, vascular graft, of 6mm and greater diameter
Regulation Description Vascular graft prosthesis.
Product CodeDSY
Regulation Number 870.3450
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORP.
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  SUBSTANTIALLY EQUIVALENT 16
BAXTER HEALTHCARE CORP.
  1
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  4
  SUBSTANTIALLY EQUIVALENT 14
CARBOMEDICS, INC.
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
INTER-VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 3
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
POSSIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 5
SULZER
  SUBSTANTIALLY EQUIVALENT 4
TAYSIDE FLOW TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 2
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 3
VASCUTEK LTD.
  3
  SUBSTANTIALLY EQUIVALENT 16
W.L. GORE & ASSOCIATES,INC
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  5
  SUBSTANTIALLY EQUIVALENT 14

Device Problems
Leak 146
No code available 121
Manufacturing or shipping issue associated with device 87
Occlusion within device 52
No Known Device Problem 51
No Information 49
Device operates differently than expected 47
Torn material 46
Device remains implanted 34
Other (for use when an appropriate device code cannot be identified) 34
Device clogged 33
Unknown (for use when the device problem is not known) 23
Tears, rips, holes in device, device material 21
Hole in material 21
Peeled 16
Mislabeled 14
Foreign material 13
Unraveled material 13
Material separation 11
Explanted 11
Material integrity issue 11
Material frayed 9
Delamination 9
Migration of device or device component 8
Break 7
Product quality issue 6
Replace 5
Split 5
Blockage within device or device component 5
Detachment of device component 5
Foreign material present in device 5
Material deformation 4
Kinked 4
Material rupture 4
Use of Device Issue 4
Size incorrect for patient 4
Material puncture 3
Fracture 3
Entrapment of device or device component 3
Repair 3
Device packaging compromised 2
Human-Device Interface Issue 2
Device handling issue 2
Elective removal 2
Elective replacement 2
Contamination during use 2
Material discolored 2
Fluid leak 2
Sticking 2
Stretched 2
Improper or incorrect procedure or method 2
Reaction 2
Deployment issue 2
Device Contamination with biological material 2
Material perforation 2
Fungus in device environment 2
Implant, removal of 1
Surgical graft, failure of 1
Device Issue 1
Tear, rip or hole in device packaging 1
Cut in material 1
Bacterial contamination of device 1
Out-of-box failure 1
Device markings issue 1
Malposition of device 1
Patient-device incompatibility 1
Biological environmental factor 1
Difficult to remove 1
Shelf life exceeded 1
Device inoperable 1
Suture line separation 1
Loose or intermittent connection 1
Mechanical issue 1
Melted 1
Nonstandard device or device component 1
Disconnection 1
Electro-magnetic interference (EMI) 1
Design/structure problem 1
Biofilm coating in device 1
Coagulation in device or device ingredient 1
Component(s), broken 1
Filling problem 1
Fire 1
Failure to remove enzymatic cleaner 1
Material erosion 1
Device expiration issue 1
Material Distortion 1
Material Protrusion 1
Improper flow or infusion 1
Infusion or flow issue 1
Device or device component damaged by another device 1
Total Device Problems 1017

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 5 1 0 2 1 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Sep-30-2013
2 Bard Peripheral Vascular Inc II Feb-09-2016
3 Intervascular S.A.S. II Apr-28-2010
4 Intervascular S.A.S. II Apr-23-2010
5 Maquet Cardiovascular, LLC II Mar-07-2011
6 Maquet Cardiovascular, LLC II Jul-22-2010
7 Maquet Cardiovascular, LLC II May-14-2010
8 Maquet Cardiovascular, LLC II Feb-26-2010
9 Terumo Cardiovascular Systems Corporation II Nov-18-2013
10 Vascutek, Ltd. II Aug-18-2014

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