TPLC - Total Product Life Cycle

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Device	left atrial appendage clip, implantable
Regulation Description	Implantable clip.
Definition	Intended to occlude the left atrial appendage.
Product Code	PZX
Regulation Number	878.4300
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	46	46
Mechanical Problem	32	32
Malposition of Device	11	11
Use of Device Problem	6	6
Material Too Rigid or Stiff	4	4
Sharp Edges	4	4
Product Quality Problem	4	4
Fluid/Blood Leak	4	4
Activation, Positioning or Separation Problem	2	2
No Apparent Adverse Event	2	2
Device Slipped	1	1
Separation Problem	1	1
Device Markings/Labelling Problem	1	1
No Fail-Safe Mechanism	1	1
Positioning Problem	1	1
Difficult to Remove	1	1
Positioning Failure	1	1
Obstruction of Flow	1	1
Misassembled	1	1
Packaging Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Failure to Fire	1	1
Activation Failure	1	1
Migration	1	1
Appropriate Term/Code Not Available	1	1
Firing Problem	1	1
Mechanical Jam	1	1
No Flow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	34	34
Hemorrhage/Bleeding	22	22
Cardiac Perforation	13	13
Ventricular Fibrillation	8	8
Obstruction/Occlusion	7	7
Thrombosis/Thrombus	6	6
Arrhythmia	4	4
Atrial Fibrillation	4	4
Abrasion	4	4
Stroke/CVA	3	3
Cardiac Arrest	3	3
Transient Ischemic Attack	3	3
Insufficient Information	3	3
Unspecified Tissue Injury	3	3
Ischemia Stroke	3	3
Perforation	2	2
Pericardial Effusion	2	2
Tachycardia	2	2
Stenosis	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Non specific EKG/ECG Changes	1	1
High Blood Pressure/ Hypertension	1	1
Coagulation Disorder	1	1
Anemia	1	1
Cardiac Tamponade	1	1
Great Vessel Perforation	1	1
Loss of consciousness	1	1
Heart Block	1	1