TPLC - Total Product Life Cycle

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Device	temporary coronary saphenous vein bypass graft for embolic protection
Regulation Description	Percutaneous catheter.
Product Code	NFA
Regulation Number	870.1250
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	94	94
Difficult to Remove	91	91
Adverse Event Without Identified Device or Use Problem	39	39
Difficult or Delayed Positioning	23	23
Difficult to Advance	12	12
Failure to Advance	7	7
Break	6	6
Entrapment of Device	5	5
Mechanical Problem	4	4
Device-Device Incompatibility	3	3
Device Difficult to Setup or Prepare	3	3
Detachment of Device or Device Component	3	3
Fracture	3	3
Activation, Positioning or Separation Problem	2	2
Defective Device	2	2
Retraction Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Material Split, Cut or Torn	1	1
Migration or Expulsion of Device	1	1
Device Markings/Labelling Problem	1	1
Unsealed Device Packaging	1	1
Positioning Problem	1	1
Contamination	1	1
Device Damaged by Another Device	1	1
Material Separation	1	1
Activation Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	178	178
No Consequences Or Impact To Patient	17	17
Stroke/CVA	4	4
Vasoconstriction	4	4
Embolism/Embolus	4	4
Transient Ischemic Attack	4	4
Foreign Body In Patient	4	4
Insufficient Information	4	4
Myocardial Infarction	4	4
Obstruction/Occlusion	3	3
High Blood Pressure/ Hypertension	2	2
Stenosis	2	2
Ischemia Stroke	2	2
Device Embedded In Tissue or Plaque	2	2
Dysphasia	1	1
Vascular Dissection	1	1
Hematoma	1	1
Perforation	1	1
Cardiac Arrest	1	1
No Known Impact Or Consequence To Patient	1	1
Intracranial Hemorrhage	1	1
Paralysis	1	1
Nerve Damage	1	1
Coma	1	1
Bradycardia	1	1
Perforation of Vessels	1	1
Loss of Vision	1	1
Low Blood Pressure/ Hypotension	1	1