• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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)
2017 2018 2019 2020 2021 2022
12 6 4 4 4 3

MDR Year MDR Reports MDR Events
2017 61 61
2018 123 123
2019 62 62
2020 55 55
2021 48 48
2022 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 91 91
Adverse Event Without Identified Device or Use Problem 63 63
Difficult to Remove 45 45
Failure to Advance 41 41
Improper or Incorrect Procedure or Method 31 31
Difficult to Advance 24 24
Material Deformation 24 24
Leak/Splash 23 23
Off-Label Use 20 20
Material Rupture 17 17
Activation Failure 15 15
Migration or Expulsion of Device 14 14
Break 14 14
Premature Separation 13 13
Inflation Problem 9 9
Material Separation 9 9
Positioning Failure 8 8
Migration 7 7
Device Operates Differently Than Expected 7 7
Activation, Positioning or SeparationProblem 6 6
Detachment of Device or Device Component 6 6
Malposition of Device 6 6
Unintended System Motion 6 6
Difficult To Position 6 6
Premature Activation 5 5
Difficult or Delayed Activation 5 5
Deformation Due to Compressive Stress 4 4
Material Twisted/Bent 4 4
Insufficient Information 4 4
Difficult or Delayed Positioning 4 4
Contamination 4 4
Fracture 4 4
Deflation Problem 3 3
Physical Resistance/Sticking 3 3
Patient-Device Incompatibility 3 3
Unstable 2 2
Defective Device 2 2
Infusion or Flow Problem 2 2
Appropriate Term/Code Not Available 2 2
Material Split, Cut or Torn 2 2
Positioning Problem 2 2
Detachment Of Device Component 2 2
Fluid Leak 2 2
Difficult to Insert 2 2
Retraction Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Obstruction of Flow 2 2
Expiration Date Error 1 1
Separation Failure 1 1
Material Too Rigid or Stiff 1 1
Component Missing 1 1
Out-Of-Box Failure 1 1
Product Quality Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Sticking 1 1
Device Inoperable 1 1
Kinked 1 1
Material Fragmentation 1 1
Occlusion Within Device 1 1
Loose or Intermittent Connection 1 1
Difficult to Fold, Unfold or Collapse 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Torn Material 1 1
Output Problem 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Physical Resistance 1 1
Blocked Connection 1 1
Delivery System Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 115 115
No Clinical Signs, Symptoms or Conditions 53 53
No Known Impact Or Consequence To Patient 29 29
Hemorrhage/Bleeding 24 24
No Code Available 22 22
Occlusion 20 20
Thrombosis 19 19
No Patient Involvement 19 19
Ischemia 18 18
Death 15 15
Foreign Body In Patient 14 14
Vascular Dissection 13 13
Stenosis 12 12
Hematoma 12 12
Rupture 8 8
Device Embedded In Tissue or Plaque 7 7
No Information 7 7
Perforation 7 7
Pseudoaneurysm 7 7
Renal Failure 6 6
Pain 5 5
Insufficient Information 5 5
Blood Loss 5 5
Collapse 4 4
Embolism 4 4
Aneurysm 4 4
Arrhythmia 3 3
Vessel Or Plaque, Device Embedded In 3 3
Infarction, Cerebral 3 3
Obstruction/Occlusion 3 3
Impaired Healing 2 2
Respiratory Failure 2 2
Multiple Organ Failure 2 2
Embolism/Embolus 2 2
Calcium Deposits/Calcification 2 2
Intimal Dissection 2 2
Pneumonia 2 2
Nausea 2 2
Hypersensitivity/Allergic reaction 2 2
Low Blood Pressure/ Hypotension 2 2
Unspecified Infection 2 2
Inflammation 1 1
Failure of Implant 1 1
High Blood Pressure/ Hypertension 1 1
Hemorrhage, Cerebral 1 1
Intracranial Hemorrhage 1 1
Myocardial Infarction 1 1
Pneumothorax 1 1
Rash 1 1
Renal Disease, End Stage 1 1
Pulmonary Embolism 1 1
Adult Respiratory Distress Syndrome 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Angina 1 1
Stroke/CVA 1 1
Wound Dehiscence 1 1
Embolus 1 1
Extravasation 1 1
Fever 1 1
Fistula 1 1
Thrombosis/Thrombus 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Organ Dehiscence 1 1
Claudication 1 1
Test Result 1 1
Spinal Cord Injury 1 1
Paraplegia 1 1
Respiratory Tract Infection 1 1
Cardiogenic Shock 1 1
Discomfort 1 1
Injury 1 1
Paralysis 1 1
Sepsis 1 1
Swelling 1 1
Thrombus 1 1
Vomiting 1 1
Weakness 1 1
Dizziness 1 1

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