TPLC - Total Product Life Cycle

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Device	drug-eluting peripheral transluminal angioplasty catheter
Definition	A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, femoral, and iliofemoral.
Product Code	ONU
Device Class	3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	0	0	0	2	17	23	14	12	15	16	21	20	20	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3858	8261
Material Rupture	368	612
Inflation Problem	210	210
Burst Container or Vessel	146	146
Material Twisted/Bent	104	104
Defective Device	90	90
Leak/Splash	84	84
Difficult to Remove	78	78
Deflation Problem	69	69
Detachment of Device or Device Component	58	58
Occlusion Within Device	40	40
Entrapment of Device	35	35
Insufficient Information	29	29
Device-Device Incompatibility	22	22
Material Deformation	20	20
Failure to Deflate	19	19
Difficult to Advance	17	17
Material Integrity Problem	15	15
Material Separation	15	15
Device Operates Differently Than Expected	14	14
Failure to Advance	13	13
Break	13	13
Retraction Problem	12	12
Use of Device Problem	9	9
Device Expiration Issue	9	9
Material Split, Cut or Torn	7	7
Fracture	7	7
Torn Material	7	7
Difficult to Insert	7	7
Off-Label Use	5	5
Patient-Device Incompatibility	4	4
Material Puncture/Hole	4	4
Stretched	4	4
Appropriate Term/Code Not Available	4	4
Obstruction of Flow	4	4
Device Contamination with Chemical or Other Material	4	4
Device Dislodged or Dislocated	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Crack	3	3
Improper or Incorrect Procedure or Method	2	2
Contamination /Decontamination Problem	2	2
Scratched Material	2	2
Tear, Rip or Hole in Device Packaging	2	2
No Apparent Adverse Event	2	2
Infusion or Flow Problem	2	2
Device Difficult to Setup or Prepare	2	2
Device Markings/Labelling Problem	2	2
Packaging Problem	1	1
Protective Measures Problem	1	1
Difficult or Delayed Positioning	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Reocclusion	1569	1569
Stenosis	751	760
No Clinical Signs, Symptoms or Conditions	565	809
No Consequences Or Impact To Patient	515	515
Death	424	1278
Occlusion	255	255
Vascular Dissection	240	364
Insufficient Information	188	920
Obstruction/Occlusion	139	627
Restenosis	120	120
Intimal Dissection	96	96
Thrombosis	81	81
Thrombosis/Thrombus	80	80
Ischemia	78	78
Pain	64	64
Injury	52	52
Claudication	50	50
Thrombus	47	47
Patient Problem/Medical Problem	41	41
Arteriosclerosis/ Atherosclerosis	38	38
Embolism	36	36
Embolism/Embolus	31	33
Cancer	28	638
Hemorrhage/Bleeding	28	28
Pseudoaneurysm	25	25
Perforation	25	25
Necrosis	23	23
Reaction	23	23
Hypersensitivity/Allergic reaction	22	22
Aneurysm	19	19
Unspecified Infection	18	18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	384
No Code Available	18	18
No Known Impact Or Consequence To Patient	18	18
Hematoma	15	15
Gangrene	14	14
Swelling	12	12
Myocardial Infarction	12	12
No Information	10	10
Foreign Body In Patient	10	10
Pneumonia	10	132
Stroke/CVA	10	10
Unspecified Tissue Injury	9	9
Perforation of Vessels	9	9
Cardiac Arrest	8	252
Swelling/ Edema	7	7
Renal Failure	7	7
Vasoconstriction	6	6
Cellulitis	6	6
Peripheral Vascular Disease	6	7

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Vascular, Inc.	II	May-06-2022