TPLC - Total Product Life Cycle

• Device: implant, intragastric for morbid obesity
• Product Code: LTI
• Device Class: 3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
4	7	10	1	2	3	6	14	14	32	21	5	3	2	4	2

MDR Year	MDR Reports	MDR Events
2014	563	563
2015	556	556
2016	514	514
2017	528	528
2018	453	453
2019	334	334
2020	165	165
2021	193	193
2022	609	609
2023	975	975
2024	180	180

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	1155	1155
Adverse Event Without Identified Device or Use Problem	857	857
Insufficient Information	846	846
Deflation Problem	570	570
Device Slipped	405	405
Patient-Device Incompatibility	213	213
Leak/Splash	195	195
Unintended Deflation	185	185
Free or Unrestricted Flow	158	158
Migration or Expulsion of Device	156	156
Inflation Problem	109	109
Material Erosion	87	87
Appropriate Term/Code Not Available	86	86
Migration	75	75
Air/Gas in Device	68	68
Device Operates Differently Than Expected	57	57
Break	51	51
No Apparent Adverse Event	46	46
Detachment of Device or Device Component	38	38
Use of Device Problem	34	34
Disconnection	30	30
Device Issue	24	24
Fracture	18	18
Patient Device Interaction Problem	18	18
Obstruction of Flow	17	17
Material Separation	17	17
Detachment Of Device Component	15	15
Malposition of Device	14	14
Device Dislodged or Dislocated	14	14
Improper or Incorrect Procedure or Method	13	13
Mechanical Problem	13	13
Inadequacy of Device Shape and/or Size	12	12
Unintended Movement	12	12
Extrusion	11	11
Material Integrity Problem	10	10
Difficult to Remove	9	9
Defective Device	8	8
Therapeutic or Diagnostic Output Failure	8	8
Output Problem	7	7
Material Rupture	7	7
Device Inoperable	7	7
Filling Problem	7	7
Entrapment of Device	6	6
Hole In Material	6	6
Kinked	6	6
Nonstandard Device	6	6
Loose or Intermittent Connection	6	6
Burst Container or Vessel	6	6
Material Twisted/Bent	6	6
Material Deformation	6	6
Expulsion	6	6
Infusion or Flow Problem	5	5
Material Perforation	5	5
Defective Component	4	4
Component Missing	4	4
Material Puncture/Hole	4	4
Material Protrusion/Extrusion	4	4
Positioning Problem	4	4
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Human-Device Interface Problem	4	4
Compatibility Problem	3	3
Difficult to Advance	3	3
Connection Problem	3	3
Packaging Problem	3	3
Premature Separation	3	3
Failure to Deflate	3	3
Partial Blockage	3	3
Complete Blockage	3	3
Crack	3	3
Tear, Rip or Hole in Device Packaging	3	3
Device Or Device Fragments Location Unknown	3	3
Short Fill	3	3
Material Too Rigid or Stiff	2	2
Premature Activation	2	2
Increase in Pressure	2	2
Off-Label Use	2	2
Split	2	2
Material Discolored	2	2
Material Disintegration	2	2
Biofilm coating in Device	2	2
Corroded	2	2
Material Fragmentation	2	2
Separation Problem	2	2
Material Split, Cut or Torn	2	2
Pressure Problem	2	2
Torn Material	2	2
Activation, Positioning or Separation Problem	2	2
Improper Flow or Infusion	2	2
Inadequate Instructions for Non-Healthcare Professional	1	1
Improper Device Output	1	1
Gas/Air Leak	1	1
Difficult to Open or Close	1	1
Device Contamination with Chemical or Other Material	1	1
Mechanical Jam	1	1
No Flow	1	1
Firing Problem	1	1
Device Fell	1	1
Misassembly by Users	1	1
Inadequate Instructions for Healthcare Professional	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	1090	1090
Vomiting	1007	1007
Pain	666	667
Insufficient Information	541	541
Nausea	435	436
Abdominal Pain	414	414
No Clinical Signs, Symptoms or Conditions	385	385
Patient Problem/Medical Problem	347	347
Erosion	316	317
Dysphagia/ Odynophagia	187	188
Regurgitation	186	186
Obstruction/Occlusion	179	180
No Code Available	128	128
Unspecified Infection	126	126
No Known Impact Or Consequence To Patient	118	118
Dehydration	113	113
Pyrosis/Heartburn	111	111
Hernia	110	110
Inflammation	108	108
Weight Changes	96	96
No Information	93	93
Ulcer	72	72
No Consequences Or Impact To Patient	64	64
Malaise	63	64
Perforation	50	50
Internal Organ Perforation	49	49
Hemorrhage/Bleeding	44	44
Adhesion(s)	42	43
Scar Tissue	38	38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	38	38
Fever	37	37
Constipation	35	35
Discomfort	32	32
Complaint, Ill-Defined	32	32
Diarrhea	32	32
Death	32	32
Sepsis	31	31
Dyspnea	31	31
Aspiration/Inhalation	30	30
Abdominal Distention	30	30
Abdominal Cramps	30	30
Irritation	29	29
Chest Pain	27	27
Perforation of Esophagus	27	27
Blood Loss	24	24
Foreign Body In Patient	24	24
Gastritis	24	24
Pneumonia	24	24
Other (for use when an appropriate patient code cannot be identified)	24	24
Surgical procedure, additional	23	23
Necrosis	22	22
Fatigue	20	20
Anemia	18	18
Abscess	17	17
Device Embedded In Tissue or Plaque	17	17
Gastrointestinal Regurgitation	17	17
Cramp(s)	16	16
Bacterial Infection	14	14
Hair Loss	14	14
Pancreatitis	14	14
Ischemia	13	13
Swelling	13	13
Dizziness	12	12
Ulceration	11	11
Hypersensitivity/Allergic reaction	11	11
Achalasia	11	11
Pulmonary Embolism	11	11
Choking	11	11
Depression	10	10
Prolapse	10	10
Autoimmune Disorder	10	10
Cardiac Arrest	10	10
Burning Sensation	10	10
Tachycardia	9	9
Seroma	9	9
Renal Failure	9	9
Syncope	9	9
Flatus	9	9
Stomach Ulceration	9	9
Fluid Discharge	8	8
Injury	8	8
Fistula	8	8
Laceration(s)	8	8
Urinary Tract Infection	8	8
Weakness	8	8
Therapeutic Response, Decreased	8	8
Tissue Damage	7	7
Septic Shock	7	7
Nerve Damage	7	7
Surgical procedure	7	7
Anxiety	7	7
Coma	7	7
Not Applicable	7	7
Sleep Dysfunction	7	7
Unspecified Gastrointestinal Problem	7	7
Implant Pain	6	6
Palpitations	6	6
Bowel Perforation	6	6
Laceration(s) of Esophagus	6	6
Muscle Spasm(s)	6	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Allergan	II	May-02-2011
2	Allergan	II	Nov-18-2010
3	Apollo Endosurgery Inc	II	Aug-10-2018
4	Apollo Endosurgery Inc	II	Sep-30-2014
5	Ethicon Endo-Surgery Inc	II	Nov-05-2013
6	Ethicon Endo-Surgery Inc	II	Nov-02-2010
7	Obalon Therapeutics Inc	II	Apr-28-2020
8	Reshape Medical Inc	II	Nov-10-2016
9	Reshape Medical Inc	II	Aug-17-2016