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
Peeled/Delaminated	8	8
Unsealed Device Packaging	8	8
Tear, Rip or Hole in Device Packaging	7	7
Material Rupture	7	7
Use of Device Problem	7	9
Material Split, Cut or Torn	6	6
Fluid/Blood Leak	5	5
Appropriate Term/Code Not Available	5	5
Detachment of Device or Device Component	5	5
Patient Device Interaction Problem	5	5
Leak/Splash	4	4
Calcified	4	4
Product Quality Problem	4	4
Packaging Problem	4	4
Thickening of Material	3	3
Material Deformation	3	3
Structural Problem	3	3
Contamination /Decontamination Problem	3	3
Material Puncture/Hole	3	3
Material Disintegration	3	3
Migration or Expulsion of Device	3	3
Break	3	3
Degraded	2	2
Material Too Rigid or Stiff	2	2
Obstruction of Flow	2	2
Material Integrity Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Lack of Effect	2	2
Delivered as Unsterile Product	2	2
Patient-Device Incompatibility	2	2
Material Separation	2	2
Crack	2	2
Migration	2	2
Moisture Damage	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Shipping Damage or Problem	1	1
Contamination	1	1
Material Erosion	1	1
Device Handling Problem	1	1
Partial Blockage	1	1
Restricted Flow rate	1	1
Device Sensing Problem	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
Hemorrhage/Bleeding	10	15
Mitral Valve Insufficiency/ Regurgitation	10	10
Insufficient Information	9	11
Thrombosis/Thrombus	9	19
No Patient Involvement	8	8
No Code Available	8	8
Mitral Valve Stenosis	7	7
Endocarditis	7	7
Pain	7	7
No Known Impact Or Consequence To Patient	7	7
Injury	6	6
Failure of Implant	6	6
Adhesion(s)	5	5
Pulmonary Valve Insufficiency/ Regurgitation	5	5
Wound Dehiscence	5	5
Valvular Insufficiency/ Regurgitation	5	12
No Consequences Or Impact To Patient	5	5
Rupture	5	5
Arrhythmia	5	10
Aneurysm	5	5
Seroma	5	5
Meningitis	4	4
Death	4	4
Pericardial Effusion	4	4
Reaction	4	4
Sepsis	4	14
Not Applicable	3	3
Aortic Insufficiency	3	3
Unspecified Respiratory Problem	3	15
Foreign Body Reaction	3	3
Unspecified Tissue Injury	3	3
Calcium Deposits/Calcification	3	3
Pneumonia	3	14
Chest Pain	3	3
Nerve Damage	3	3
Dyspnea	3	3
Impaired Healing	2	2
Thrombus	2	2
Pulmonary Hypertension	2	2
Respiratory Insufficiency	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