TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
0	0	0	10	7	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	93	93
Difficult to Advance	32	32
Difficult to Remove	28	28
Improper or Incorrect Procedure or Method	27	27
Failure to Advance	21	21
Deformation Due to Compressive Stress	18	18
Material Separation	14	14
Break	13	13
Material Split, Cut or Torn	9	9
Material Deformation	8	8
Ambient Temperature Problem	8	8
Device Damaged by Another Device	7	7
Activation Failure	7	7
Device Dislodged or Dislocated	7	7
Patient-Device Incompatibility	5	5
Stretched	4	4
Difficult or Delayed Activation	4	4
Material Rupture	4	4
Leak/Splash	3	3
Peeled/Delaminated	3	3
Off-Label Use	2	2
Material Twisted/Bent	2	2
Inflation Problem	2	2
Migration	2	2
Difficult to Flush	1	1
Insufficient Information	1	1
Difficult to Insert	1	1
Material Too Rigid or Stiff	1	1
Difficult or Delayed Positioning	1	1
Material Too Soft/Flexible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	97	97
Obstruction/Occlusion	52	52
Pain	34	34
Stenosis	22	22
Thrombosis/Thrombus	14	14
Unspecified Tissue Injury	11	11
Vascular Dissection	5	5
Ischemia	5	5
Pseudoaneurysm	4	4
Hypersensitivity/Allergic reaction	3	3
Embolism/Embolus	2	2
Swelling/ Edema	2	2
Unspecified Vascular Problem	2	2
Fatigue	1	1
Inflammation	1	1
Diminished Pulse Pressure	1	1
Numbness	1	1
Insufficient Information	1	1
Prolapse	1	1
Perforation of Vessels	1	1
Hemorrhage/Bleeding	1	1
Device Embedded In Tissue or Plaque	1	1