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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
ADMEDUS LTD
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORMATRIX CARDIOVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRYOLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 62
Insufficient Information 36
Restricted Flow rate 31
Device Operates Differently Than Expected 20
Device Contamination with Chemical or Other Material 14
Delamination 14
Material Rupture 13
Material Distortion 10
Nonstandard device 9
Appropriate Term/Code Not Available 8
Material Split, Cut or Torn 8
Hole In Material 7
Material Integrity Problem 7
Material Frayed 6
Migration or Expulsion of Device 5
Material Deformation 5
Material Separation 5
Material Erosion 4
Product Quality Problem 4
Peeled / Delaminated 4
Detachment of Device or device Component 4
Calcified 3
Material Puncture / Hole 3
Crack 2
Patient Device Interaction Problem 2
Device Markings / Labelling Problem 2
Manufacturing, Packaging or Shipping Problem 2
Patient-Device Incompatibility 2
Missing Information 2
Material Fragmentation 1
Off-Label Use 1
Contamination / decontamination Problem 1
No Apparent Adverse Event 1
Degraded 1
Unsealed Device Packaging 1
Fracture 1
Device Dislodged or Dislocated 1
Break 1
Fluid Leak 1
Occlusion Within Device 1
Loss of or Failure to Bond 1
Microbial Contamination of Device 1
Physical Property Issue 1
Partial Blockage 1
Device Contaminated during manufacture or shipping 1
Torn Material 1
Total Device Problems 311

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Aug-12-2016
2 CryoLife, Inc. II Apr-25-2019
3 CryoLife, Inc. II Oct-18-2018
4 CryoLife, Inc. II Jun-21-2018
5 GETINGE US SALES LLC II Mar-20-2018
6 Synovis Surgical Innovations, Inc. I May-29-2015

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