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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
LIMFLOW INC.
  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 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 40 40
Fracture 22 22
Break 21 21
Detachment of Device or Device Component 14 14
Detachment Of Device Component 7 7
Difficult to Remove 6 6
Entrapment of Device 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Material Fragmentation 3 3
Leak/Splash 3 3
Migration or Expulsion of Device 2 2
Material Frayed 2 2
Material Puncture/Hole 2 2
Improper or Incorrect Procedure or Method 2 2
Device Operates Differently Than Expected 2 2
Failure to Advance 2 2
Device Dislodged or Dislocated 2 2
Physical Resistance 1 1
Device Or Device Fragments Location Unknown 1 1
Mechanical Jam 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Material Perforation 1 1
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
Device Fell 1 1
Failure To Adhere Or Bond 1 1
Component Falling 1 1
Contamination 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Peeled/Delaminated 1 1
Off-Label Use 1 1
Device Slipped 1 1
Stretched 1 1
Unraveled Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
Foreign Body In Patient 23 23
No Known Impact Or Consequence To Patient 18 18
No Consequences Or Impact To Patient 16 16
Device Embedded In Tissue or Plaque 12 12
No Code Available 6 6
Insufficient Information 6 6
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
Myocardial Infarction 1 1
Tricuspid Insufficiency 1 1
Arrhythmia 1 1
Calcium Deposits/Calcification 1 1
Stroke/CVA 1 1
Great Vessel Perforation 1 1
Patient Problem/Medical Problem 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Blood Loss 1 1

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