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	106	106
Incomplete or Missing Packaging	100	100
Device Contamination with Chemical or Other Material	54	54
Insufficient Information	26	26
Product Quality Problem	14	18
Nonstandard Device	13	13
Missing Information	13	13
Difficult to Open or Remove Packaging Material	12	12
Unsealed Device Packaging	12	12
Off-Label Use	11	11
Material Split, Cut or Torn	6	6
Leak/Splash	5	5
Fluid/Blood Leak	4	4
Tear, Rip or Hole in Device Packaging	4	4
Packaging Problem	4	4
Material Rupture	4	4
Appropriate Term/Code Not Available	3	3
Patient Device Interaction Problem	3	3
Patient-Device Incompatibility	3	3
Use of Device Problem	2	2
Obstruction of Flow	2	2
Lack of Effect	2	2
Material Integrity Problem	2	2
Material Puncture/Hole	2	2
Material Disintegration	2	5
Peeled/Delaminated	2	2
Migration	2	2
Calcified	2	2
Improper or Incorrect Procedure or Method	2	2
Contamination /Decontamination Problem	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Degraded	1	1
Unraveled Material	1	1
Material Too Rigid or Stiff	1	1
Contamination	1	1
Delivered as Unsterile Product	1	1
Device Handling Problem	1	1
Restricted Flow rate	1	1
Output Problem	1	1
Break	1	1
Unexpected Therapeutic Results	1	1
Fungus in Device Environment	1	1
Optical Discoloration	1	1
Incomplete Coaptation	1	1
Separation Problem	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	203	204
Stenosis	42	42
Insufficient Information	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Restenosis	10	10
Hematoma	9	9
Unspecified Infection	8	8
Pseudoaneurysm	8	8
Aneurysm	7	7
Failure of Implant	6	9
Thrombosis/Thrombus	6	6
Pulmonary Valve Insufficiency/ Regurgitation	5	5
Hemorrhage/Bleeding	5	5
Rupture	4	4
Valvular Insufficiency/ Regurgitation	4	4
Aortic Valve Insufficiency/ Regurgitation	4	4
Meningitis	4	4
Pericardial Effusion	3	3
Unspecified Tissue Injury	3	3
Obstruction/Occlusion	3	3
Nerve Damage	3	3
Pain	3	3
Adhesion(s)	3	3
Dyspnea	3	3
Chest Pain	3	3
Wound Dehiscence	2	2
Aortic Valve Stenosis	2	2
Bacterial Infection	2	2
Endocarditis	2	2
Pleural Effusion	2	2
Inflammation	2	2
Sepsis	2	2
Heart Failure/Congestive Heart Failure	2	2
Fungal Infection	2	2
Mitral Valve Insufficiency/ Regurgitation	2	2
Unspecified Respiratory Problem	2	2
Muscle/Tendon Damage	1	1
Pulmonary Hypertension	1	1
Asystole	1	1
Embolism/Embolus	1	1
No Patient Involvement	1	1
Tissue Breakdown	1	1
Fluid Discharge	1	1
Foreign Body In Patient	1	1
Vascular Dissection	1	1
Reaction to Medicinal Component of Device	1	1
Local Reaction	1	1
Perforation	1	1
Infiltration into Tissue	1	1
Post Operative Wound Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Artivion, Inc	II	Aug-08-2024
2	Baxter Healthcare Corporation	II	Jan-05-2024
3	Glycar SA Pty., Ltd.	I	Nov-25-2025
4	Vascutek, Ltd.	II	Sep-24-2021