TPLC - Total Product Life Cycle

• Device: agents, embolic, for treatment of uterine fibroids
• Product Code: NAJ
• Regulation Number: 870.3300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	4	4
2020	1	1
2021	4	4
2022	20	20
2023	3	3
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	31	31
Failure to Deliver	2	2
Failure to Infuse	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	8	8
Necrosis	7	7
Insufficient Information	6	6
Abdominal Pain	5	5
Fever	5	5
Nausea	4	4
Hemorrhage/Bleeding	4	4
Vomiting	4	4
Unspecified Infection	3	3
Fatigue	3	3
Inflammation	3	3
Renal Failure	3	3
Low Blood Pressure/ Hypotension	2	2
No Clinical Signs, Symptoms or Conditions	2	2
No Consequences Or Impact To Patient	2	2
Paralysis	2	2
Pulmonary Infarction	2	2
Swelling/ Edema	2	2
Heart Failure/Congestive Heart Failure	2	2
Bradycardia	2	2
Decreased Appetite	1	1
Urinary Tract Infection	1	1
Fistula	1	1
Pulmonary Embolism	1	1
Ischemia Stroke	1	1
Sexual Dysfunction	1	1
Constipation	1	1
Loss of Vision	1	1
Cardiac Enzyme Elevation	1	1
Unspecified Heart Problem	1	1
Cerebrospinal Fluid Leakage	1	1
Unspecified Tissue Injury	1	1
Pulmonary Edema	1	1
Prolapse	1	1
Dehydration	1	1
Discomfort	1	1
Urinary Retention	1	1
Diarrhea	1	1
Thrombosis/Thrombus	1	1
Chills	1	1
Burning Sensation	1	1
Weakness	1	1
Confusion/ Disorientation	1	1
Electrolyte Imbalance	1	1
Skin Inflammation/ Irritation	1	1
Hematuria	1	1
Dizziness	1	1
Sepsis	1	1
Liver Damage/Dysfunction	1	1
Hypersensitivity/Allergic reaction	1	1