Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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)
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 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 85 85
Difficult to Remove 42 42
Failure to Advance 36 36
Difficult to Advance 28 28
Material Deformation 25 25
Off-Label Use 23 23
Adverse Event Without Identified Device or Use Problem 22 22
Activation Failure 20 20
Premature Separation 15 15
Improper or Incorrect Procedure or Method 15 15
Material Separation 14 14
Break 14 14
Material Rupture 12 12
Leak/Splash 7 7
Migration 7 7
Unintended System Motion 7 7
Inflation Problem 6 6
Difficult or Delayed Activation 6 6
Fracture 5 5
Positioning Failure 4 4
Contamination 4 4
Malposition of Device 4 4
Detachment of Device or Device Component 4 4
Deformation Due to Compressive Stress 3 3
Activation, Positioning or Separation Problem 3 3
Defective Device 2 2
Deflation Problem 2 2
Difficult or Delayed Positioning 2 2
Failure to Fold 2 2
Material Twisted/Bent 2 2
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Packaging Problem 1 1
Appropriate Term/Code Not Available 1 1
Difficult to Fold, Unfold or Collapse 1 1
Difficult to Insert 1 1
Migration or Expulsion of Device 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Patient-Device Incompatibility 1 1
Device-Device Incompatibility 1 1
Inadequacy of Device Shape and/or Size 1 1
Unstable 1 1
Expiration Date Error 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 109 109
No Consequences Or Impact To Patient 65 65
Foreign Body In Patient 14 14
No Known Impact Or Consequence To Patient 11 11
No Patient Involvement 9 9
Device Embedded In Tissue or Plaque 9 9
Vascular Dissection 7 7
No Code Available 7 7
Insufficient Information 7 7
Stenosis 7 7
Pain 6 6
Embolism/Embolus 4 4
Thrombosis/Thrombus 3 3
Thrombosis 3 3
Hemorrhage/Bleeding 3 3
Ischemia 3 3
Occlusion 3 3
Nausea 2 2
Intimal Dissection 2 2
Renal Failure 2 2
Collapse 2 2
Obstruction/Occlusion 2 2
Blood Loss 2 2
No Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pseudoaneurysm 1 1
Discomfort 1 1
Test Result 1 1
Sepsis 1 1
Perforation 1 1
Dizziness 1 1
Rupture 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Calcium Deposits/Calcification 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Death 1 1
Embolism 1 1
Vessel Or Plaque, Device Embedded In 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Inflammation 1 1

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