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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device replacement heart-valve
Regulation Description Replacement heart valve.
Definition Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
Product CodeDYE
Regulation Number 870.3925
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019
38 13 22 34 27 8

Device Problems
Insufficient Information 3583
Calcified 1031
Degraded 900
Appropriate Term/Code Not Available 843
Incomplete Coaptation 496
Perivalvular Leak 351
Gradient Increase 317
Heart Valve Leaflet 96
Adverse Event Without Identified Device or Use Problem 84
Torn Material 80
Restricted Flow rate 76
Inadequacy of Device Shape and/or Size 70
Leak / Splash 50
Material Deformation 50
Obstruction of Flow 23
Material Too Rigid or Stiff 16
Patient-Device Incompatibility 13
Occlusion Within Device 12
Difficult to Open or Close 11
No Apparent Adverse Event 11
Malposition of device 11
Material Split, Cut or Torn 10
Device Dislodged or Dislocated 10
Material Separation 9
Hole In Material 9
Device Operates Differently Than Expected 8
Patient Device Interaction Problem 6
Difficult to Fold or Unfold 6
Material Distortion 5
Fracture 5
Device Abrasion From Instrument Or Another Object 4
Material Perforation 4
Folded 4
Detachment Of Device Component 3
Mechanical Problem 3
Improper Flow or Infusion 3
Retraction Problem 3
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 3
Activation, Positioning or Separation Problem 3
Structural Problem 2
Particulates 2
Escape 2
Material Discolored 2
Material Integrity Problem 2
Delivery System Failure 2
Biocompatibility 2
Kinked 2
Device Contamination with Chemical or Other Material 2
Incorrect Device Or Component Shipped 2
Device Damaged by Another Device 2
Device Packaging Compromised 1
Device Handling Problem 1
Unsealed Device Packaging 1
Loss of Power 1
Off-Label Use 1
Complete Blockage 1
Material Fragmentation 1
Sticking 1
Material Rupture 1
Difficult to Insert 1
Entrapment of Device 1
Material Erosion 1
Detachment of Device or device Component 1
Break 1
Difficult To Position 1
Failure to Unfold or Unwrap 1
Defective Device 1
Device Appears to Trigger Rejection 1
Tear, Rip or Hole in Device Packaging 1
Valve 1
Contamination During Use 1
Bent 1
Migration or Expulsion of Device 1
Device Operational Issue 1
Material Puncture / Hole 1
Delamination 1
Unknown (for use when the device problem is not known) 1
Component Missing 1
Activation Failure Including Expansion Failures 1
Connection Problem 1
Coagulation in Device or device Ingredient 1
Difficult or Delayed Positioning 1
Total Device Problems 8276

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Cardiovascular Surgery-the Heart Valve Division II Sep-11-2014
2 Medtronic Inc II Jun-26-2019

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