TPLC - Total Product Life Cycle

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Device	patch, pledget and intracardiac, petp, ptfe, polypropylene
Product Code	DXZ
Regulation Number	870.3470
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	159	211
Device Contamination with Chemical or Other Material	57	57
Insufficient Information	35	35
Off-Label Use	27	35
Nonstandard Device	13	13
Improper or Incorrect Procedure or Method	12	12
Difficult to Open or Remove Packaging Material	12	12
Unsealed Device Packaging	8	8
Peeled/Delaminated	8	8
Material Rupture	7	7
Use of Device Problem	7	9
Tear, Rip or Hole in Device Packaging	7	7
Material Split, Cut or Torn	6	6
Fluid/Blood Leak	5	5
Appropriate Term/Code Not Available	5	5
Patient Device Interaction Problem	5	5
Detachment of Device or Device Component	5	5
Packaging Problem	4	4
Calcified	4	4
Leak/Splash	4	4
Product Quality Problem	4	4
Structural Problem	3	3
Material Deformation	3	3
Material Disintegration	3	3
Thickening of Material	3	3
Material Puncture/Hole	3	3
Migration or Expulsion of Device	3	3
Break	3	3
Contamination /Decontamination Problem	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Material Integrity Problem	2	2
Patient-Device Incompatibility	2	2
Crack	2	2
Migration	2	2
Material Separation	2	2
Material Too Rigid or Stiff	2	2
Obstruction of Flow	2	2
Delivered as Unsterile Product	2	2
Lack of Effect	2	2
Degraded	2	2
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Partial Blockage	1	1
Contamination	1	1
Device Sensing Problem	1	1
Incomplete or Missing Packaging	1	1
Moisture Damage	1	1
Separation Problem	1	1
Material Frayed	1	1
Device Contaminated During Manufacture or Shipping	1	1
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	83	83
Stenosis	67	91
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Unspecified Infection	18	18
Aortic Valve Insufficiency/ Regurgitation	14	19
Inflammation	14	14
Pseudoaneurysm	11	11
Hematoma	11	11
Restenosis	10	33
Aortic Valve Stenosis	10	10
Mitral Valve Insufficiency/ Regurgitation	10	10
Hemorrhage/Bleeding	10	15
Insufficient Information	9	11
Thrombosis/Thrombus	9	19
No Patient Involvement	8	8
No Code Available	8	8
Pain	7	7
No Known Impact Or Consequence To Patient	7	7
Mitral Valve Stenosis	7	7
Endocarditis	7	7
Injury	6	6
Failure of Implant	6	6
Wound Dehiscence	5	5
Arrhythmia	5	10
Seroma	5	5
Pulmonary Valve Insufficiency/ Regurgitation	5	5
No Consequences Or Impact To Patient	5	5
Adhesion(s)	5	5
Aneurysm	5	5
Valvular Insufficiency/ Regurgitation	5	12
Rupture	5	5
Reaction	4	4
Pericardial Effusion	4	4
Sepsis	4	14
Meningitis	4	4
Death	4	4
Unspecified Tissue Injury	3	3
Calcium Deposits/Calcification	3	3
Pneumonia	3	14
Unspecified Respiratory Problem	3	15
Dyspnea	3	3
Foreign Body Reaction	3	3
Nerve Damage	3	3
Chest Pain	3	3
Not Applicable	3	3
Aortic Insufficiency	3	3
Respiratory Insufficiency	2	2
Valvular Stenosis	2	2
Bacterial Infection	2	2
Thrombus	2	2

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	Vascutek, Ltd.	II	Sep-24-2021