TPLC - Total Product Life Cycle

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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	169	221
Device Contamination with Chemical or Other Material	56	56
Insufficient Information	27	27
Off-Label Use	26	34
Product Quality Problem	14	14
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
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
Material Puncture/Hole	3	3
Material Disintegration	3	3
Contamination /Decontamination Problem	2	2
Material Too Rigid or Stiff	2	2
Obstruction of Flow	2	2
Structural Problem	2	2
Material Integrity Problem	2	2
Lack of Effect	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Patient-Device Incompatibility	2	2
Detachment of Device or Device Component	2	2
Migration	2	2
Break	2	2
Moisture Damage	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Degraded	1	1
Unraveled Material	1	1
Contamination	1	1
Delivered as Unsterile Product	1	1
Device Handling Problem	1	1
Partial Blockage	1	1
Material Separation	1	1
Material Erosion	1	1
Device Sensing Problem	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
Calcified	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	101	101
Stenosis	64	88
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Insufficient Information	19	21
Restenosis	16	39
Aortic Valve Insufficiency/ Regurgitation	14	19
Thrombosis/Thrombus	12	22
Unspecified Infection	11	11
Pseudoaneurysm	10	10
Mitral Valve Insufficiency/ Regurgitation	10	10
Hematoma	10	10
Aortic Valve Stenosis	9	9
Mitral Valve Stenosis	7	7
Inflammation	7	7
Hemorrhage/Bleeding	6	11
Endocarditis	6	6
Failure of Implant	6	6
Aneurysm	6	6
Injury	6	6
Pulmonary Valve Insufficiency/ Regurgitation	5	5
Arrhythmia	5	10
Sepsis	5	15
Pain	5	5
No Patient Involvement	5	5
Valvular Insufficiency/ Regurgitation	5	12
Meningitis	4	4
Seroma	4	4
Pericardial Effusion	4	4
Rupture	4	4
Wound Dehiscence	4	4
No Known Impact Or Consequence To Patient	3	3
Death	3	3
Adhesion(s)	3	3
Chest Pain	3	3
Nerve Damage	3	3
Dyspnea	3	3
Not Applicable	3	3
Unspecified Respiratory Problem	3	15
Pneumonia	3	14
Reaction	3	3
Unspecified Tissue Injury	3	3
Obstruction/Occlusion	2	2
Low Cardiac Output	2	23
Impaired Healing	2	2
Cardiac Arrest	2	2
Foreign Body Reaction	2	2
Respiratory Insufficiency	2	2
Pulmonary Hypertension	2	2
Pleural Effusion	2	2
Drug Resistant Bacterial Infection	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