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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device patch, pledget and intracardiac, petp, ptfe, polypropylene
Regulation Description Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
Product CodeDXZ
Regulation Number 870.3470
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
BIOVASCULAR INC
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRYOLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 3
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAST BIOSURGERY USA INC.
  SE - WITH LIMITATIONS 1
PNEUMEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIMED
  SUBSTANTIALLY EQUIVALENT 1
SHELHIGH, INC.
  SUBSTANTIALLY EQUIVALENT 3
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 2
SOMANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
SULZER
  SUBSTANTIALLY EQUIVALENT 2
SYNOVIS SURGICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 2
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 1
VASCUTEK LTD.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 13

Device Problems
Unknown (for use when the device problem is not known) 139
No Known Device Problem 39
Restricted flowrate 27
Device operates differently than expected 20
No Information 20
Material rupture 13
Material Distortion 10
Leak 9
Delamination 7
Device remains implanted 6
No code available 6
Nonstandard device or device component 5
Material frayed 5
Hole in material 4
Material integrity issue 4
Foreign material present in device 3
Explanted 3
Product quality issue 2
Device markings issue 2
Fungus in device environment 2
Implant, removal of 1
Surgical graft, failure of 1
Material separation 1
Failure to sterilize 1
Other (for use when an appropriate device code cannot be identified) 1
Material deformation 1
Torn material 1
Reaction 1
Replace 1
Unsealed device packaging 1
Particulates 1
Perivalvular leak 1
Loss of or failure to bond 1
Material fragmentation 1
Migration of device or device component 1
Total Device Problems 341

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

Recalls
Manufacturer Recall Class Date Posted
1 CryoLife, Inc. II Jan-23-2014
2 CryoLife, Inc. II Mar-04-2011
3 Maquet Cardiovascular, LLC II Jul-22-2010
4 Synovis Surgical Innovations, Inc. I May-29-2015
5 Synovis Surgical Innovations, Inc. II Nov-18-2013
6 Synovis Surgical Inovation Div. of II Sep-21-2010

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