TPLC - Total Product Life Cycle

• Device: prosthesis, esophageal
• Product Code: ESW
• Regulation Number: 878.3610
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
M.I. TECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
M.I.TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAEWOONG MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TAEWOONG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	86	86
2019	169	169
2020	155	155
2021	78	78
2022	107	107
2023	52	52

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation, Positioning or Separation Problem	177	177
Activation Failure	137	137
Migration	88	88
Activation Problem	69	69
Adverse Event Without Identified Device or Use Problem	67	67
Positioning Problem	63	63
Material Deformation	46	46
Break	44	44
Use of Device Problem	43	43
Difficult to Remove	34	34
Migration or Expulsion of Device	34	34
Improper or Incorrect Procedure or Method	26	26
Positioning Failure	25	25
Material Integrity Problem	23	23
Appropriate Term/Code Not Available	21	21
Insufficient Information	20	20
Failure to Advance	18	18
Detachment of Device or Device Component	16	16
Fracture	12	12
Obstruction of Flow	11	11
Physical Resistance/Sticking	11	11
Off-Label Use	10	10
Difficult or Delayed Positioning	9	9
Material Twisted/Bent	9	9
Premature Activation	8	8
Material Separation	8	8
Unraveled Material	5	5
Structural Problem	5	5
Device Markings/Labelling Problem	5	5
Difficult to Advance	4	4
Material Perforation	4	4
Human-Device Interface Problem	4	4
Infusion or Flow Problem	3	3
Unsealed Device Packaging	3	3
Difficult to Insert	2	2
Kinked	2	2
Material Erosion	2	2
Component Missing	2	2
Malposition of Device	2	2
Sharp Edges	2	2
Material Split, Cut or Torn	2	2
Separation Problem	1	1
Wrong Label	1	1
Deformation Due to Compressive Stress	1	1
Delivery System Failure	1	1
Packaging Problem	1	1
Failure to Deliver	1	1
Difficult to Open or Close	1	1
Dent in Material	1	1
Separation Failure	1	1
Difficult or Delayed Activation	1	1
Defective Device	1	1
Failure to Fire	1	1
Fluid/Blood Leak	1	1
Entrapment of Device	1	1
Loss of or Failure to Bond	1	1
Detachment Of Device Component	1	1
Misassembled	1	1
Reflux within Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	216	216
No Consequences Or Impact To Patient	198	198
No Known Impact Or Consequence To Patient	55	55
No Code Available	41	41
Obstruction/Occlusion	24	24
Dysphagia/ Odynophagia	23	23
Hemorrhage/Bleeding	17	17
Pain	17	17
Perforation	13	13
Erosion	12	12
Death	10	10
Fistula	8	8
Discomfort	8	8
Insufficient Information	8	8
No Information	7	7
Blood Loss	7	7
Occlusion	7	7
Vomiting	7	7
Failure of Implant	7	7
Fever	6	6
Chest Pain	6	6
Dysphasia	6	6
Pneumonia	6	6
Regurgitation	5	5
Nausea	5	5
Perforation of Esophagus	4	4
Injury	3	3
Laceration(s) of Esophagus	3	3
Aspiration/Inhalation	3	3
Foreign Body In Patient	3	3
Difficulty Chewing	2	2
Cough	2	2
Abdominal Pain	2	2
Peritonitis	2	2
Excessive Tear Production	2	2
Hernia	1	1
Pulmonary Dysfunction	1	1
Tissue Damage	1	1
Ulceration	1	1
Skin Tears	1	1
Abrasion	1	1
Airway Obstruction	1	1
Anemia	1	1
Laceration(s)	1	1
Pyrosis/Heartburn	1	1
Dyspnea	1	1
Erythema	1	1
Hematemesis	1	1
Decreased Appetite	1	1
No Patient Involvement	1	1
Intraoperative Pain	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Taewoong Medical Co., Ltd.	II	Feb-14-2020