TPLC - Total Product Life Cycle

• Device: glue, surgical, arteries
• Product Code: MUQ
• Device Class: 3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
2	1	0	1	1	0	1	5	3	3	5	0	2	1	1	0

MDR Year	MDR Reports	MDR Events
2014	40	40
2015	56	56
2016	28	28
2017	31	31
2018	25	25
2019	39	39
2020	25	25
2021	25	25
2022	12	12
2023	7	7
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	173	173
Insufficient Information	62	62
Appropriate Term/Code Not Available	23	23
Device Operates Differently Than Expected	10	10
Failure To Adhere Or Bond	7	7
Off-Label Use	6	6
Material Fragmentation	5	5
Migration or Expulsion of Device	4	4
Use of Device Problem	3	3
Loss of or Failure to Bond	3	3
Patient-Device Incompatibility	3	3
Migration	3	3
Contamination	2	2
Improper or Incorrect Procedure or Method	2	2
Material Separation	2	2
Occlusion Within Device	1	1
Peeled/Delaminated	1	1
Incorrect Or Inadequate Test Results	1	1
Malposition of Device	1	1
Degraded	1	1
Material Erosion	1	1
Kinked	1	1
Leak/Splash	1	1
Break	1	1
Complete Blockage	1	1
Clumping in Device or Device Ingredient	1	1
Material Too Soft/Flexible	1	1
Patient Device Interaction Problem	1	1
Biocompatibility	1	1
Chemical Problem	1	1
Positioning Problem	1	1
Unintended Movement	1	1
Device Damaged by Another Device	1	1
Device Contamination with Chemical or Other Material	1	1
Improper Chemical Reaction	1	1
Material Deformation	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pseudoaneurysm	60	60
Unspecified Infection	48	48
Inflammation	26	26
Death	22	22
Embolism	15	15
No Code Available	15	15
Fever	14	14
No Information	12	12
Reaction	11	11
Aneurysm	10	10
Necrosis	8	8
Rupture	8	8
Aortic Dissection	7	7
Vascular Dissection	7	7
Blood Loss	6	6
Pain	6	6
Abscess	6	6
Anaphylactic Shock	6	6
Cerebrospinal Fluid Leakage	6	6
Fistula	6	6
Stroke/CVA	5	5
Seroma	5	5
Thromboembolism	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Neurological Deficit/Dysfunction	4	4
Myocardial Infarction	4	4
Ischemia	4	4
Hemorrhage/Bleeding	3	3
Hypersensitivity/Allergic reaction	3	3
Calcium Deposits/Calcification	3	3
Occlusion	3	3
Brain Injury	3	3
Aortic Regurgitation	3	3
Granuloma	3	3
Insufficient Information	3	3
Meningitis	3	3
Not Applicable	3	3
Fluid Discharge	3	3
Foreign Body In Patient	3	3
No Known Impact Or Consequence To Patient	3	3
Cardiac Perforation	2	2
Embolism/Embolus	2	2
No Consequences Or Impact To Patient	2	2
Alteration In Body Temperature	2	2
Coma	2	2
Fungal Infection	2	2
Obstruction/Occlusion	2	2
Stenosis	2	2
Complaint, Ill-Defined	2	2
Reaction to Medicinal Component of Device	2	2
Swelling/ Edema	2	2
Embolus	2	2
Purulent Discharge	2	2
Arrhythmia	2	2
Wound Dehiscence	2	2
Bacterial Infection	2	2
Chest Pain	2	2
Tissue Damage	2	2
Hepatitis	2	2
Low Blood Pressure/ Hypotension	1	1
Hypoxia	1	1
Itching Sensation	1	1
Laceration(s)	1	1
Mitral Regurgitation	1	1
Undesired Nerve Stimulation	1	1
Perforation	1	1
Pleural Effusion	1	1
Pneumonia	1	1
Pulmonary Dysfunction	1	1
Pulmonary Valve Stenosis	1	1
Staphylococcus Aureus	1	1
Tricuspid Regurgitation	1	1
Urinary Tract Infection	1	1
Loss of Vision	1	1
Vomiting	1	1
Weakness	1	1
Tingling	1	1
HIV, Human Immunodeficiency Virus	1	1
Discharge	1	1
Cardiac Tamponade	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Regurgitation	1	1
Cardiogenic Shock	1	1
Shock	1	1
Spinal Column Injury	1	1
Congestive Heart Failure	1	1
Cyst(s)	1	1
Infarction, Cerebral	1	1
Intimal Dissection	1	1
Syncope	1	1
Air Embolism	1	1
Atherosclerosis	1	1
Dyspnea	1	1
Edema	1	1
Endocarditis	1	1
Erythema	1	1
Fall	1	1
Headache	1	1
Hematoma	1	1
Hemoptysis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CryoLife, Inc.	II	Dec-15-2021
2	CryoLife, Inc.	II	Jul-26-2018
3	CryoLife, Inc.	II	Jun-23-2017
4	CryoLife, Inc.	II	May-30-2014
5	Siemens Medical Solutions USA, Inc	II	Nov-16-2021