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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 46
Restricted flowrate 31
No Information 21
Device operates differently than expected 20
Material rupture 15
Material Distortion 12
Leak 9
Delamination 8
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
Device markings issue 2
Material separation 2
Fungus in device environment 2
Product quality issue 2
Reaction 1
Replace 1
Unsealed device packaging 1
Particulates 1
Perivalvular leak 1
Migration of device or device component 1
Material fragmentation 1
Blockage within device or device component 1
Loss of or failure to bond 1
Crack 1
Implant, removal of 1
Surgical graft, failure of 1
Failure to sterilize 1
Other (for use when an appropriate device code cannot be identified) 1
Material deformation 1
Torn material 1
Total Device Problems 361

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 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Aug-12-2016
2 CryoLife, Inc. II Jan-23-2014
3 CryoLife, Inc. II Mar-04-2011
4 Maquet Cardiovascular, LLC II Jul-22-2010
5 Synovis Surgical Innovations, Inc. I May-29-2015
6 Synovis Surgical Innovations, Inc. II Nov-18-2013
7 Synovis Surgical Inovation Div. of II Sep-21-2010

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