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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stent, renal
Definition Stent, Renal -- a metal scaffold placed via a delivery catheter into the renal artery to maintain the lumen
Product CodeNIN
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
4 4 4 6 0 0

MDR Year MDR Reports MDR Events
2020 55 55
2021 47 47
2022 39 39
2023 47 47
2024 53 53
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 100 100
Failure to Advance 41 41
Difficult to Remove 40 40
Difficult to Advance 28 28
Material Deformation 25 25
Off-Label Use 21 21
Activation Failure 21 21
Adverse Event Without Identified Device or Use Problem 21 21
Premature Separation 15 15
Material Separation 13 13
Improper or Incorrect Procedure or Method 12 12
Material Rupture 12 12
Break 11 11
Leak/Splash 8 8
Migration 6 6
Difficult or Delayed Activation 5 5
Fracture 4 4
Unintended System Motion 4 4
Deflation Problem 3 3
Failure to Fold 2 2
Positioning Failure 2 2
Contamination 2 2
Material Twisted/Bent 2 2
Difficult or Delayed Positioning 2 2
Inflation Problem 2 2
Malposition of Device 2 2
Activation, Positioning or Separation Problem 2 2
Difficult to Insert 1 1
Obstruction of Flow 1 1
Positioning Problem 1 1
Material Integrity Problem 1 1
Defective Device 1 1
Packaging Problem 1 1
Product Quality Problem 1 1
Patient-Device Incompatibility 1 1
Inadequacy of Device Shape and/or Size 1 1
Tear, Rip or Hole in Device Packaging 1 1
Detachment of Device or Device Component 1 1
Material Puncture/Hole 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Split, Cut or Torn 1 1
Device-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 149 149
No Consequences Or Impact To Patient 33 33
Foreign Body In Patient 14 14
Device Embedded In Tissue or Plaque 11 11
Stenosis 8 8
Insufficient Information 8 8
Pain 7 7
Vascular Dissection 5 5
Embolism/Embolus 4 4
No Known Impact Or Consequence To Patient 3 3
Thrombosis/Thrombus 3 3
Thrombosis 3 3
Intimal Dissection 2 2
Nausea 2 2
No Code Available 2 2
Occlusion 2 2
Renal Failure 2 2
Collapse 2 2
Obstruction/Occlusion 2 2
No Patient Involvement 2 2
Low Blood Pressure/ Hypotension 1 1
Unspecified Vascular Problem 1 1
Hemorrhage/Bleeding 1 1
Bacterial Infection 1 1
Embolism 1 1
Calcium Deposits/Calcification 1 1
Bradycardia 1 1
Discomfort 1 1
Cardiac Arrest 1 1
Blood Loss 1 1
Rupture 1 1
Perforation 1 1
Ischemia 1 1
No Information 1 1
Test Result 1 1
Dizziness 1 1
Sepsis 1 1
Failure of Implant 1 1
Death 1 1
Stroke/CVA 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
High Blood Pressure/ Hypertension 1 1
Vessel Or Plaque, Device Embedded In 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II May-08-2020
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