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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, percutaneous retrieval
Product CodeMMX
Regulation Number 870.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
AVANTEC VASCULAR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONOCOR VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 29 29
2018 15 15
2019 17 17
2020 14 14
2021 22 22
2022 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 39 39
Fracture 22 22
Break 18 18
Detachment of Device or Device Component 13 13
Detachment Of Device Component 7 7
Difficult to Remove 4 4
Device Contaminated During Manufacture or Shipping 4 4
Material Fragmentation 3 3
Entrapment of Device 3 3
Leak/Splash 3 3
Material Frayed 2 2
Material Puncture/Hole 2 2
Device Operates Differently Than Expected 2 2
Improper or Incorrect Procedure or Method 2 2
Failure to Advance 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Dislodged or Dislocated 2 2
Output Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Migration 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Physical Resistance 1 1
Device Or Device Fragments Location Unknown 1 1
Material Perforation 1 1
Device-Device Incompatibility 1 1
Mechanical Jam 1 1
Device Slipped 1 1
Stretched 1 1
Unraveled Material 1 1
Migration or Expulsion of Device 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Failure To Adhere Or Bond 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
Foreign Body In Patient 22 22
No Known Impact Or Consequence To Patient 18 18
No Consequences Or Impact To Patient 16 16
Device Embedded In Tissue or Plaque 10 10
No Code Available 6 6
Insufficient Information 5 5
No Information 4 4
No Patient Involvement 3 3
Tricuspid Regurgitation 2 2
Vessel Or Plaque, Device Embedded In 2 2
Embolism 2 2
Low Blood Pressure/ Hypotension 2 2
Tricuspid Insufficiency 1 1
Arrhythmia 1 1
Calcium Deposits/Calcification 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Blood Loss 1 1
Patient Problem/Medical Problem 1 1

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