TPLC - Total Product Life Cycle

show TPLC since

Device	patch, pledget and intracardiac, petp, ptfe, polypropylene
Regulation Description	Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
Product Code	DXZ
Regulation Number	870.3470
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	173	225
Device Contamination with Chemical or Other Material	56	56
Insufficient Information	30	30
Off-Label Use	26	34
Product Quality Problem	14	17
Improper or Incorrect Procedure or Method	13	13
Nonstandard Device	13	13
Unsealed Device Packaging	13	13
Difficult to Open or Remove Packaging Material	12	12
Missing Information	10	10
Use of Device Problem	7	9
Material Split, Cut or Torn	6	6
Peeled/Delaminated	6	6
Tear, Rip or Hole in Device Packaging	6	6
Material Rupture	5	5
Fluid/Blood Leak	4	4
Leak/Splash	4	4
Appropriate Term/Code Not Available	4	4
Packaging Problem	4	4
Thickening of Material	3	3
Patient Device Interaction Problem	3	3
Patient-Device Incompatibility	3	3
Material Puncture/Hole	3	3
Material Disintegration	3	6
Contamination /Decontamination Problem	2	2
Material Too Rigid or Stiff	2	2
Obstruction of Flow	2	2
Structural Problem	2	2
Lack of Effect	2	2
Material Integrity Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Detachment of Device or Device Component	2	2
Migration	2	2
Break	2	2
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Degraded	1	1
Unraveled Material	1	1
Moisture Damage	1	1
Contamination	1	1
Delivered as Unsterile Product	1	1
Device Handling Problem	1	1
Partial Blockage	1	1
Material Separation	1	1
Device Sensing Problem	1	1
Material Erosion	1	1
Restricted Flow rate	1	1
Output Problem	1	1
Unexpected Therapeutic Results	1	1
Fungus in Device Environment	1	1
Optical Discoloration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	115	115
Stenosis	64	88
Insufficient Information	20	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Restenosis	16	39
Aortic Valve Insufficiency/ Regurgitation	14	19
Unspecified Infection	12	12
Thrombosis/Thrombus	12	22
Pseudoaneurysm	11	11
Mitral Valve Insufficiency/ Regurgitation	10	10
Hematoma	10	10
Aortic Valve Stenosis	9	9
Aneurysm	8	8
Mitral Valve Stenosis	7	7
Inflammation	7	7
Hemorrhage/Bleeding	6	11
Endocarditis	6	6
Failure of Implant	6	9
Injury	6	6
Pulmonary Valve Insufficiency/ Regurgitation	5	5
Pain	5	5
No Patient Involvement	5	5
Pericardial Effusion	5	5
Valvular Insufficiency/ Regurgitation	5	12
Adhesion(s)	5	5
Arrhythmia	5	10
Sepsis	5	15
Wound Dehiscence	4	4
Meningitis	4	4
Rupture	4	4
Seroma	4	4
Death	3	3
Unspecified Respiratory Problem	3	15
Unspecified Tissue Injury	3	3
Cardiac Arrest	3	3
Reaction	3	3
Pneumonia	3	14
Dyspnea	3	3
No Known Impact Or Consequence To Patient	3	3
Not Applicable	3	3
Pleural Effusion	3	3
Chest Pain	3	3
Nerve Damage	3	3
Impaired Healing	2	2
Respiratory Insufficiency	2	2
Pulmonary Hypertension	2	2
Bacterial Infection	2	2
Drug Resistant Bacterial Infection	2	2
Heart Failure/Congestive Heart Failure	2	2
Valvular Stenosis	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Artivion, Inc	II	Aug-08-2024
2	Baxter Healthcare Corporation	II	Jan-05-2024
3	CryoLife, Inc.	II	Dec-21-2020
4	Vascutek, Ltd.	II	Sep-24-2021