TPLC - Total Product Life Cycle

• 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
VASCUTEK, LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	44	44
2019	55	55
2020	121	183
2021	80	81
2022	77	80
2023	40	40
2024	49	49
2025	122	122
2026	36	36

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	157	209
Incomplete or Missing Packaging	101	101
Device Contamination with Chemical or Other Material	64	64
Insufficient Device Problem Information	58	58
Off-Label Use	28	36
Material Split, Cut or Torn	18	18
Nonstandard Device	16	16
Missing Information	15	15
Product Quality Problem	14	15
Unsealed Device Packaging	13	13
Improper or Incorrect Procedure or Method	13	13
Difficult to Open or Remove Packaging Material	12	12
Fluid/Blood Leak	9	9
Material Rupture	8	8
Tear, Rip or Hole in Device Packaging	8	8
Use of Device Problem	7	9
Peeled/Delaminated	6	6
Detachment of Device or Device Component	5	5
Leak/Splash	5	5
Patient Device Interaction Problem	5	5
Calcified	4	4
Patient-Device Incompatibility	4	4
Material Puncture/Hole	4	4
Packaging Problem	4	4
Appropriate Device Problem Term/Code Not Available	4	4
Thickening of Material	3	3
Material Separation	3	3
Device Appears to Trigger Rejection	3	3
Material Deformation	3	3
Delivered as Unsterile Product	3	3
Migration or Expulsion of Device	3	3
Lack of Effect	2	2
Degraded	2	2
Contamination /Decontamination Problem	2	2
Material Integrity Problem	2	2
Obstruction of Flow	2	2
Migration	2	2
Device Stenosis	1	1
Separation Problem	1	1
Material Too Rigid or Stiff	1	1
Microbial Contamination of Device	1	1
Unraveled Material	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Device Handling Problem	1	1
No Apparent Adverse Event	1	1
Torn Material	1	1
Optical Discoloration	1	1
Material Distortion	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	209	210
Stenosis	69	93
Insufficient Information	47	49
Unspecified Infection	26	26
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	19	19
Restenosis	16	39
Aneurysm	16	16
Hemorrhage/Blood Loss/Bleeding	16	21
No Patient Involvement	15	15
Hematoma	15	15
Inflammation	15	15
Pseudoaneurysm	15	15
Aortic Valve Insufficiency/ Regurgitation	14	19
No Code Available	14	14
Thrombosis/Thrombus	12	22
Mitral Valve Insufficiency/ Regurgitation	10	10
Aortic Valve Stenosis	10	10
Wound Dehiscence	10	10
No Consequences Or Impact To Patient	9	9
No Known Impact Or Consequence To Patient	9	9
Pain	8	8
Endocarditis	8	8
Adhesion(s)	8	8
Mitral Valve Stenosis	7	7
Sepsis	6	16
Injury	6	6
Reaction	6	6
Pulmonary Valve Insufficiency/ Regurgitation	6	6
Pericardial Effusion	6	6
Failure of Implant	6	9
Valvular Insufficiency/ Regurgitation	5	12
Arrhythmia	5	10
Rupture	5	5
Not Applicable	5	5
Seroma	5	5
Death	4	4
No Information	4	4
Meningitis	4	4
Pneumonia	3	14
Pleural Effusion	3	3
Dyspnea	3	3
Foreign Body Reaction	3	3
Cardiac Tamponade	3	3
Heart Failure/Congestive Heart Failure	3	3
Obstruction/Occlusion	3	3
Unspecified Tissue Injury	3	3
Nerve Damage	3	3
Unspecified Respiratory Problem	3	15
Medical device site infection	3	3
Perforation	3	3

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	CryoLife, Inc.	II	Apr-25-2019
5	CryoLife, Inc.	II	Oct-18-2018
6	CryoLife, Inc.	II	Jun-21-2018
7	GETINGE US SALES LLC	II	Mar-20-2018
8	Glycar SA Pty., Ltd.	I	Nov-25-2025
9	Vascutek, Ltd.	II	Sep-24-2021