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
Incomplete or Missing Packaging	100	100
Adverse Event Without Identified Device or Use Problem	91	91
Device Contamination with Chemical or Other Material	54	54
Insufficient Device Problem Information	37	37
Missing Information	13	13
Unsealed Device Packaging	12	12
Product Quality Problem	12	13
Nonstandard Device	12	12
Difficult to Open or Remove Packaging Material	12	12
Off-Label Use	11	11
Material Split, Cut or Torn	10	10
Fluid/Blood Leak	9	9
Tear, Rip or Hole in Device Packaging	5	5
Leak/Splash	5	5
Material Rupture	4	4
Packaging Problem	4	4
Appropriate Device Problem Term/Code Not Available	3	3
Patient Device Interaction Problem	3	3
Patient-Device Incompatibility	3	3
Device Appears to Trigger Rejection	3	3
Peeled/Delaminated	2	2
Delivered as Unsterile Product	2	2
Migration	2	2
Obstruction of Flow	2	2
Material Integrity Problem	2	2
Lack of Effect	2	2
Improper or Incorrect Procedure or Method	2	2
Use of Device Problem	2	2
Restricted Flow rate	1	1
Material Disintegration	1	1
Device Handling Problem	1	1
Unraveled Material	1	1
Separation Problem	1	1
Contamination	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Degraded	1	1
Biocompatibility	1	1
Calcified	1	1
Device Stenosis	1	1
Material Puncture/Hole	1	1
Material Too Rigid or Stiff	1	1
Optical Discoloration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	206	207
Insufficient Information	44	44
Stenosis	42	42
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	17	17
Restenosis	10	10
Unspecified Infection	9	9
Hematoma	9	9
Pseudoaneurysm	8	8
Hemorrhage/Blood Loss/Bleeding	8	8
Aneurysm	7	7
Failure of Implant	6	9
Pulmonary Valve Insufficiency/ Regurgitation	6	6
Thrombosis/Thrombus	6	6
Wound Dehiscence	6	6
Adhesion(s)	4	4
Valvular Insufficiency/ Regurgitation	4	4
Meningitis	4	4
Rupture	4	4
Aortic Valve Insufficiency/ Regurgitation	4	4
Medical device site infection	3	3
Endocarditis	3	3
Nerve Damage	3	3
Heart Failure/Congestive Heart Failure	3	3
Dyspnea	3	3
Unspecified Tissue Injury	3	3
Perforation	3	3
Pericardial Effusion	3	3
Obstruction/Occlusion	3	3
Chest Pain	3	3
Pain	3	3
Inflammation	2	2
Bacterial Infection	2	2
Pleural Effusion	2	2
Fungal Infection	2	2
Sepsis	2	2
Mitral Valve Insufficiency/ Regurgitation	2	2
Unspecified Respiratory Problem	2	2
Aortic Valve Stenosis	2	2
Low Oxygen Saturation	1	1
Asystole	1	1
Calcium Deposits/Calcification	1	1
Tissue Breakdown	1	1
Local Reaction	1	1
Reaction to Medicinal Component of Device	1	1
Headache	1	1
Hearing Impairment	1	1
Fluid Discharge	1	1
Chemical Exposure	1	1
Cardiac Tamponade	1	1
No Patient Involvement	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