TPLC - Total Product Life Cycle

• Device: tissue adhesive for use in embolization of brain arteriovenous malformations
• Product Code: KGG
• Device Class: 3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
3	6	1	0	1	1	2	2	2	2	2	0	0	0	2	1

MDR Year	MDR Reports	MDR Events
2016	3	3
2017	10	10
2019	7	7
2020	12	12
2021	10	10
2022	5	5
2023	7	7
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	40	40
Appropriate Term/Code Not Available	4	4
Chemical Problem	4	4
Migration or Expulsion of Device	3	3
Delivered as Unsterile Product	1	1
Therapy Delivered to Incorrect Body Area	1	1
Device Operates Differently Than Expected	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	9	9
Embolism	7	7
Stroke/CVA	5	5
No Consequences Or Impact To Patient	5	5
No Clinical Signs, Symptoms or Conditions	5	5
Headache	4	4
Thromboembolism	3	3
Neurological Deficit/Dysfunction	3	3
Ischemia Stroke	3	3
Embolism/Embolus	3	3
Ruptured Aneurysm	2	2
Hydrocephalus	2	2
Infarction, Cerebral	2	2
Low Blood Pressure/ Hypotension	2	2
Intracranial Hemorrhage	2	2
Nerve Damage	2	2
Aneurysm	1	1
Hemorrhage, Intraventricular	1	1
Hemorrhage, Subarachnoid	1	1
Unspecified Infection	1	1
Ischemia	1	1
Muscle Weakness	1	1
Death	1	1
Edema	1	1
Hematoma	1	1
Hemorrhage/Bleeding	1	1
Hemorrhage, Cerebral	1	1
Vascular Dissection	1	1
Distress	1	1
Respiratory Failure	1	1
Confusion/ Disorientation	1	1
Occlusion	1	1
Paralysis	1	1
Seizures	1	1
Urinary Retention	1	1
Perforation of Vessels	1	1
Visual Disturbances	1	1
Weakness	1	1
Thrombosis/Thrombus	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Codman & Shurtleff, Inc.	I	Jan-23-2014