TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	101	101
Pacing Problem	97	97
Incorrect Measurement	56	56
Deflation Problem	51	51
Incorrect, Inadequate or Imprecise Result or Readings	50	50
Inflation Problem	49	49
Leak/Splash	41	41
Adverse Event Without Identified Device or Use Problem	36	36
Burst Container or Vessel	36	36
Detachment of Device or Device Component	26	26
Difficult to Advance	24	24
Material Split, Cut or Torn	22	22
Fluid/Blood Leak	20	20
Failure to Deflate	20	20
Break	19	19
No Pacing	17	17
Material Separation	16	16
Difficult to Remove	13	13
Failure to Capture	12	12
No Device Output	12	12
Physical Resistance/Sticking	11	11
Material Deformation	10	10
Material Puncture/Hole	9	9
Appropriate Term/Code Not Available	9	9
Unable to Obtain Readings	8	8
Difficult or Delayed Positioning	8	8
Material Integrity Problem	6	6
Obstruction of Flow	6	6
Defective Device	5	5
Material Fragmentation	5	5
Difficult to Insert	5	5
Material Twisted/Bent	5	5
Failure to Advance	4	4
Connection Problem	4	4
Contamination	4	4
Activation, Positioning or Separation Problem	4	4
Component Missing	4	4
Crack	3	3
Malposition of Device	3	3
Insufficient Information	3	3
Tear, Rip or Hole in Device Packaging	3	3
Therapeutic or Diagnostic Output Failure	3	3
Inaccurate Information	3	3
Separation Problem	3	3
Gas/Air Leak	3	3
Device Contamination with Chemical or Other Material	2	2
Capturing Problem	2	2
Insufficient Flow or Under Infusion	2	2
Use of Device Problem	2	2
Degraded	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	582	582
No Consequences Or Impact To Patient	66	66
Insufficient Information	65	65
No Known Impact Or Consequence To Patient	40	40
Hemorrhage/Bleeding	17	17
Cardiac Tamponade	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Low Blood Pressure/ Hypotension	6	6
Hemoptysis	6	6
Great Vessel Perforation	6	6
Cardiac Arrest	6	6
Cardiac Perforation	6	6
No Patient Involvement	6	6
Vascular Dissection	5	5
No Information	5	5
Needle Stick/Puncture	4	4
Arrhythmia	3	3
Low Oxygen Saturation	3	3
Failure of Implant	3	3
Perforation	3	3
Dyspnea	3	3
Device Embedded In Tissue or Plaque	2	2
Aortic Valve Stenosis	2	2
Unspecified Vascular Problem	2	2
Pseudoaneurysm	2	2
Swelling/ Edema	2	2
Cough	2	2
Perforation of Vessels	2	2
Tachycardia	2	2
Extravasation	2	2
Anaphylactic Shock	2	2
Bradycardia	2	2
Pain	2	2
Foreign Body In Patient	2	2
Rupture	2	2
Respiratory Arrest	2	2
Physical Entrapment	1	1
Discomfort	1	1
Chest Pain	1	1
Thrombosis/Thrombus	1	1
Complete Heart Block	1	1
Ectopic Heartbeat	1	1
Atrial Fibrillation	1	1
Embolism/Embolus	1	1
Tricuspid Valve Insufficiency/ Regurgitation	1	1
Heart Block	1	1
Bronchial Hemorrhage	1	1
Thrombus	1	1
Hypersensitivity/Allergic reaction	1	1
Pulmonary Embolism	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Edwards Lifesciences, LLC	II	Apr-12-2023