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

Premarket Reviews
Manufacturer	Decision
TAMABIO
	SUBSTANTIALLY EQUIVALENT	1
1. K240775 PeriBeam® Pericardial Membrane

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	107	107
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
Tear, Rip or Hole in Device Packaging	5	5
Fluid/Blood Leak	4	4
Packaging Problem	4	4
Material Rupture	4	4
Device Appears to Trigger Rejection	3	3
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
Migration	2	2
Peeled/Delaminated	2	2
Calcified	2	2
Improper or Incorrect Procedure or Method	2	2
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 /Decontamination Problem	1	1
Delivered as Unsterile Product	1	1
Contamination	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	204	205
Stenosis	42	42
Insufficient Information	20	20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Restenosis	10	10
Unspecified Infection	9	9
Hematoma	9	9
Pseudoaneurysm	8	8
Aneurysm	7	7
Failure of Implant	6	9
Thrombosis/Thrombus	6	6
Hemorrhage/Bleeding	5	5
Pulmonary Valve Insufficiency/ Regurgitation	5	5
Meningitis	4	4
Aortic Valve Insufficiency/ Regurgitation	4	4
Valvular Insufficiency/ Regurgitation	4	4
Rupture	4	4
Adhesion(s)	3	3
Unspecified Tissue Injury	3	3
Obstruction/Occlusion	3	3
Pericardial Effusion	3	3
Pain	3	3
Dyspnea	3	3
Nerve Damage	3	3
Chest Pain	3	3
Aortic Valve Stenosis	2	2
Bacterial Infection	2	2
Endocarditis	2	2
Unspecified Respiratory Problem	2	2
Heart Failure/Congestive Heart Failure	2	2
Pleural Effusion	2	2
Mitral Valve Insufficiency/ Regurgitation	2	2
Inflammation	2	2
Fungal Infection	2	2
Sepsis	2	2
Wound Dehiscence	2	2
No Patient Involvement	1	1
Foreign Body In Patient	1	1
Cardiac Arrest	1	1
Cardiac Tamponade	1	1
Post Operative Wound Infection	1	1
Reaction to Medicinal Component of Device	1	1
Failure to Anastomose	1	1
Local Reaction	1	1
Fluid Discharge	1	1
Muscle/Tendon Damage	1	1
Asystole	1	1
Chemical Exposure	1	1
Calcium Deposits/Calcification	1	1
Perforation	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