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 scaffold, infrapopliteal, absorbable
Definition The absorbable scaffold is for improving luminal diameter for the treatment of lesions in native infrapopliteal arteries.
Product CodeNXW
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 0 0 0 10 7

MDR Year MDR Reports MDR Events
2024 29 29
2025 86 86

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 47 47
Difficult to Advance 25 25
Difficult to Remove 21 21
Improper or Incorrect Procedure or Method 17 17
Deformation Due to Compressive Stress 14 14
Failure to Advance 13 13
Break 10 10
Material Separation 9 9
Material Deformation 6 6
Material Split, Cut or Torn 5 5
Activation Failure 5 5
Device Dislodged or Dislocated 5 5
Device Damaged by Another Device 4 4
Leak/Splash 3 3
Patient-Device Incompatibility 3 3
Stretched 3 3
Difficult or Delayed Activation 3 3
Material Twisted/Bent 2 2
Material Rupture 2 2
Ambient Temperature Problem 2 2
Peeled/Delaminated 1 1
Difficult to Flush 1 1
Difficult to Insert 1 1
Material Too Rigid or Stiff 1 1
Inflation Problem 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 65 65
Obstruction/Occlusion 26 26
Pain 17 17
Stenosis 13 13
Thrombosis/Thrombus 9 9
Vascular Dissection 3 3
Hypersensitivity/Allergic reaction 2 2
Embolism/Embolus 2 2
Swelling/ Edema 2 2
Fatigue 1 1
Inflammation 1 1
Ischemia 1 1
Numbness 1 1
Insufficient Information 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1

-
-