TPLC - Total Product Life Cycle

• Device: agent, occluding, vascular, permanent
• Definition: The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels.
• Product Code: PJQ
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
3	3	7	6	5	0

MDR Year	MDR Reports	MDR Events
2019	162	162
2020	152	152
2021	161	161
2022	180	180
2023	154	154
2024	23	23

Device Problems	MDRs with this Device Problem	Events in those MDRs
Biocompatibility	378	378
Adverse Event Without Identified Device or Use Problem	371	371
Patient-Device Incompatibility	68	68
Migration or Expulsion of Device	13	13
Detachment of Device or Device Component	12	12
Activation, Positioning or Separation Problem	10	10
Defective Device	9	9
Use of Device Problem	7	7
Difficult to Remove	6	6
Obstruction of Flow	6	6
Compatibility Problem	5	5
Material Deformation	3	3
Migration	3	3
Physical Resistance/Sticking	2	2
Device Contamination with Chemical or Other Material	2	2
Difficult to Advance	2	2
Difficult to Insert	2	2
Improper or Incorrect Procedure or Method	2	2
Complete Blockage	2	2
Contamination	1	1
Fracture	1	1
Device Difficult to Setup or Prepare	1	1
Off-Label Use	1	1
Defective Component	1	1
Deformation Due to Compressive Stress	1	1
Device Damaged by Another Device	1	1
Device Dislodged or Dislocated	1	1
Infusion or Flow Problem	1	1
Positioning Problem	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	222	222
Pain	155	155
Thrombosis/Thrombus	125	125
Unspecified Infection	91	91
Patient Problem/Medical Problem	84	84
Rash	83	83
Phlebitis	81	81
Swelling/ Edema	81	81
Itching Sensation	79	79
Local Reaction	75	75
Inflammation	50	50
Reaction	48	48
Erythema	47	47
Granuloma	44	44
Foreign Body Reaction	42	42
Pulmonary Embolism	36	36
Thrombus	35	35
No Clinical Signs, Symptoms or Conditions	26	26
Swelling	24	24
Ulcer	22	22
No Consequences Or Impact To Patient	20	20
Fever	20	20
Cellulitis	19	19
Injury	19	19
Urticaria	18	18
Thrombosis	18	18
Insufficient Information	17	17
Skin Inflammation/ Irritation	17	17
Skin Irritation	15	15
Abscess	15	15
Dyspnea	12	12
Skin Discoloration	11	11
Skin Inflammation	11	11
Ecchymosis	9	9
Purulent Discharge	9	9
Hematoma	7	7
Discomfort	7	7
Ulceration	6	6
Bruise/Contusion	6	6
Stroke/CVA	6	6
Unspecified Tissue Injury	6	6
Thromboembolism	5	5
Edema	5	5
Sepsis	5	5
Septic Shock	4	4
Necrosis	4	4
Burning Sensation	4	4
Death	4	4
Irritation	4	4
Dizziness	4	4
Numbness	4	4
Obstruction/Occlusion	4	4
Embolism/Embolus	4	4
Paresthesia	4	4
Nodule	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Blood Loss	3	3
Foreign Body In Patient	3	3
Extravasation	3	3
Bacterial Infection	3	3
Anaphylactic Shock	3	3
Nerve Damage	3	3
Occlusion	3	3
Perforation	3	3
Peeling	2	2
Pneumonia	2	2
Chills	2	2
Tachycardia	2	2
Chest Pain	2	2
Fistula	2	2
Hair Loss	2	2
Low Blood Pressure/ Hypotension	2	2
No Code Available	2	2
No Known Impact Or Consequence To Patient	1	1
Tissue Breakdown	1	1
Fluid Discharge	1	1
Malaise	1	1
Impaired Healing	1	1
Sweating	1	1
Post Operative Wound Infection	1	1
Quadriplegia	1	1
Claudication	1	1
Vascular System (Circulation), Impaired	1	1
Peripheral Edema	1	1
Unspecified Nervous System Problem	1	1
Swollen Lymph Nodes/Glands	1	1
Valvular Insufficiency/ Regurgitation	1	1
Unspecified Respiratory Problem	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Failure of Implant	1	1
Hemorrhage/Bleeding	1	1
High Blood Pressure/ Hypertension	1	1
Fatigue	1	1
Cyanosis	1	1
Cyst(s)	1	1
Arrhythmia	1	1
Atrial Fibrillation	1	1
Autoimmune Disorder	1	1
Burn(s)	1	1
Embolism	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Inc.	III	May-12-2021