TPLC - Total Product Life Cycle

• Device: intracardiac patch or pledget, biologically derived
• Regulation Description: Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
• Definition: To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
• Product Code: PSQ
• Regulation Number: 870.3470
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
HELIOS CARDIO, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNOVIS LIFE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2021	10	10
2022	5	5
2023	4	4
2024	8	8
2025	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	10	10
Insufficient Information	5	5
Device Stenosis	4	4
Patient Device Interaction Problem	3	3
Microbial Contamination of Device	2	2
Separation Problem	1	1
Patient-Device Incompatibility	1	1
Unclear Information	1	1
Contamination /Decontamination Problem	1	1
Degraded	1	1
Obstruction of Flow	1	1
Appropriate Term/Code Not Available	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Stenosis	8	8
Obstruction/Occlusion	4	4
Bacterial Infection	3	3
Unspecified Infection	2	2
Inflammation	2	2
Post Operative Wound Infection	2	2
Insufficient Information	2	2
Hemorrhage/Bleeding	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Skin Inflammation/ Irritation	1	1
Thrombosis/Thrombus	1	1
Unspecified Heart Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Jan-05-2024