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
Difficult to Open or Remove Packaging Material	12	12
Unsealed Device Packaging	8	8
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
Material Disintegration	3	3
Material Puncture/Hole	3	3
Patient Device Interaction Problem	3	3
Migration	2	2
Detachment of Device or Device Component	2	2
Lack of Effect	2	2
Structural Problem	2	2
Obstruction of Flow	2	2
Material Too Rigid or Stiff	2	2
Contamination /Decontamination Problem	2	2
Material Integrity Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Break	2	2
Degraded	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Delivered as Unsterile Product	1	1
Moisture Damage	1	1
Device Handling Problem	1	1
Partial Blockage	1	1
Contamination	1	1
Material Separation	1	1
Device Sensing Problem	1	1
Patient-Device Incompatibility	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
Calcified	1	1
Incomplete Coaptation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	96	96
Stenosis	64	88
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Insufficient Information	19	21
Restenosis	15	38
Aortic Valve Insufficiency/ Regurgitation	14	19
Thrombosis/Thrombus	12	22
Unspecified Infection	11	11
Pseudoaneurysm	10	10
Hematoma	10	10
Mitral Valve Insufficiency/ Regurgitation	10	10
Aortic Valve Stenosis	9	9
Mitral Valve Stenosis	7	7
Inflammation	7	7
Hemorrhage/Bleeding	6	11
Failure of Implant	6	6
Endocarditis	6	6
Aneurysm	6	6
Injury	6	6
Pulmonary Valve Insufficiency/ Regurgitation	5	5
Arrhythmia	5	10
Sepsis	5	15
Pain	5	5
Valvular Insufficiency/ Regurgitation	5	12
No Patient Involvement	5	5
Wound Dehiscence	4	4
Meningitis	4	4
Rupture	4	4
Seroma	4	4
Pericardial Effusion	4	4
Unspecified Respiratory Problem	3	15
Unspecified Tissue Injury	3	3
Reaction	3	3
Pneumonia	3	14
Dyspnea	3	3
Nerve Damage	3	3
Chest Pain	3	3
No Known Impact Or Consequence To Patient	3	3
Death	3	3
Adhesion(s)	3	3
Not Applicable	3	3
Cardiac Arrest	2	2
Foreign Body Reaction	2	2
Impaired Healing	2	2
Respiratory Insufficiency	2	2
Pulmonary Hypertension	2	2
Low Cardiac Output	2	23
Pleural Effusion	2	2
Drug Resistant Bacterial Infection	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