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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)
2019 2020 2021 2022 2023 2024
4 4 4 4 6 0

MDR Year MDR Reports MDR Events
2019 62 62
2020 55 55
2021 47 47
2022 39 39
2023 47 47
2024 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 99 99
Difficult to Remove 46 46
Failure to Advance 42 42
Difficult to Advance 33 33
Material Deformation 26 26
Off-Label Use 24 24
Adverse Event Without Identified Device or Use Problem 24 24
Activation Failure 21 21
Improper or Incorrect Procedure or Method 17 17
Premature Separation 15 15
Material Separation 15 15
Break 14 14
Material Rupture 13 13
Leak/Splash 7 7
Unintended System Motion 7 7
Migration 7 7
Inflation Problem 6 6
Difficult or Delayed Activation 6 6
Fracture 5 5
Malposition of Device 4 4
Detachment of Device or Device Component 4 4
Contamination 4 4
Positioning Failure 4 4
Deformation Due to Compressive Stress 3 3
Deflation Problem 3 3
Activation, Positioning or Separation Problem 3 3
Material Twisted/Bent 2 2
Failure to Fold 2 2
Difficult or Delayed Positioning 2 2
Defective Device 2 2
Component Missing 1 1
Obstruction of Flow 1 1
Difficult to Insert 1 1
Positioning Problem 1 1
Material Integrity Problem 1 1
Packaging Problem 1 1
Product Quality Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Tear, Rip or Hole in Device Packaging 1 1
Expiration Date Error 1 1
Patient-Device Incompatibility 1 1
Material Puncture/Hole 1 1
Difficult to Fold, Unfold or Collapse 1 1
Physical Resistance/Sticking 1 1
Migration or Expulsion of Device 1 1
Appropriate Term/Code Not Available 1 1
Material Split, Cut or Torn 1 1
Device-Device Incompatibility 1 1
Unstable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 127 127
No Consequences Or Impact To Patient 65 65
Foreign Body In Patient 14 14
No Known Impact Or Consequence To Patient 11 11
Device Embedded In Tissue or Plaque 10 10
No Patient Involvement 9 9
Stenosis 8 8
Insufficient Information 8 8
No Code Available 7 7
Vascular Dissection 7 7
Pain 7 7
Hemorrhage/Bleeding 4 4
Embolism/Embolus 4 4
Occlusion 3 3
Ischemia 3 3
Thrombosis/Thrombus 3 3
Thrombosis 3 3
Intimal Dissection 2 2
Nausea 2 2
No Information 2 2
Renal Failure 2 2
Obstruction/Occlusion 2 2
Blood Loss 2 2
Collapse 2 2
Low Blood Pressure/ Hypotension 1 1
Unspecified Vascular Problem 1 1
Bacterial Infection 1 1
Pseudoaneurysm 1 1
Embolism 1 1
Calcium Deposits/Calcification 1 1
Bradycardia 1 1
Discomfort 1 1
Cardiac Arrest 1 1
Rupture 1 1
Perforation 1 1
Inflammation 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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