TPLC - Total Product Life Cycle

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Device	intracardiac patch or pledget, biologically derived
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
ACELL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CRYOLIFE, INC.
	SUBSTANTIALLY EQUIVALENT	1
HELIOS CARDIO INC.
	SUBSTANTIALLY EQUIVALENT	1
LEMAITRE VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
SYNOVIS LIFE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	16	16
Insufficient Information	9	9
Patient Device Interaction Problem	5	5
Appropriate Term/Code Not Available	4	4
Material Puncture/Hole	2	2
Microbial Contamination of Device	2	2
Obstruction of Flow	1	1
Patient-Device Incompatibility	1	1
Contamination /Decontamination Problem	1	1
Device Markings/Labelling Problem	1	1
Material Integrity Problem	1	1
Degraded	1	1
Fluid/Blood Leak	1	1
Separation Problem	1	1
Unclear Information	1	1
Device Stenosis	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Stenosis	4	4
Obstruction/Occlusion	3	3
Stroke/CVA	3	3
Bacterial Infection	3	3
Inflammation	3	3
Restenosis	3	3
Insufficient Information	2	2
Fistula	2	2
Hemorrhage/Bleeding	2	2
Unspecified Infection	2	2
Post Operative Wound Infection	2	2
Pseudoaneurysm	2	2
No Known Impact Or Consequence To Patient	2	2
No Information	2	2
No Code Available	2	2
Thrombosis/Thrombus	2	2
Unspecified Heart Problem	1	1
Skin Inflammation/ Irritation	1	1
Pain	1	1
Transient Ischemic Attack	1	1
Calcium Deposits/Calcification	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Aortic Valve Stenosis	1	1

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