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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 4
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
LIMFLOW INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONOCOR VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 17 17
2020 14 14
2021 22 22
2022 37 37
2023 40 40
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 29 29
Fracture 26 26
Break 21 21
Detachment of Device or Device Component 19 19
Difficult to Remove 18 18
Improper or Incorrect Procedure or Method 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Entrapment of Device 5 5
Material Fragmentation 4 4
Off-Label Use 4 4
Device Contaminated During Manufacture or Shipping 4 4
Deformation Due to Compressive Stress 3 3
Material Integrity Problem 3 3
Retraction Problem 3 3
Device-Device Incompatibility 3 3
Material Puncture/Hole 3 3
Unsealed Device Packaging 3 3
Peeled/Delaminated 3 3
Mechanical Problem 3 3
Material Split, Cut or Torn 3 3
No Apparent Adverse Event 2 2
Premature Separation 2 2
Migration or Expulsion of Device 2 2
Material Frayed 2 2
Contamination 2 2
Stretched 2 2
Unraveled Material 2 2
Failure to Advance 2 2
Material Deformation 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Output Problem 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Material Perforation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Use of Device Problem 1 1
Positioning Failure 1 1
Fluid/Blood Leak 1 1
Delivered as Unsterile Product 1 1
Activation Failure 1 1
Migration 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 71 71
Foreign Body In Patient 25 25
Insufficient Information 12 12
No Consequences Or Impact To Patient 10 10
No Known Impact Or Consequence To Patient 7 7
Device Embedded In Tissue or Plaque 5 5
No Code Available 3 3
Embolism/Embolus 2 2
No Patient Involvement 2 2
Stroke/CVA 1 1
Calcium Deposits/Calcification 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Low Blood Pressure/ Hypotension 1 1
Hemorrhage/Bleeding 1 1
Myocardial Infarction 1 1
Great Vessel Perforation 1 1

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