TPLC - Total Product Life Cycle

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Device	hybrid stent graft, thoracic aortic lesion treatment
Definition	Repair or replacement of damaged or diseased vessel of the aortic arch and descending thoracic aorta, with or without involvement of ascending aorta, using vascular grafts and/or stent grafts placed during open surgical repair.
Product Code	QSK
Device Class	3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
0	0	0	4	3	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	27	46
Adverse Event Without Identified Device or Use Problem	21	26
Material Deformation	5	5
Obstruction of Flow	5	34
Appropriate Term/Code Not Available	4	9
Defective Device	3	3
Deformation Due to Compressive Stress	3	3
Contamination /Decontamination Problem	2	2
Material Twisted/Bent	2	2
Patient-Device Incompatibility	1	1
Device Handling Problem	1	1
Migration	1	1
Difficult or Delayed Separation	1	2
Activation, Positioning or Separation Problem	1	1
Device Dislodged or Dislocated	1	1
Difficult or Delayed Activation	1	1
Fracture	1	1
Inadequacy of Device Shape and/or Size	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	18	24
Insufficient Information	12	12
Thrombosis/Thrombus	10	10
Stroke/CVA	9	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Vascular Dissection	4	33
Hematoma	3	5
Obstruction/Occlusion	3	3
Paraplegia	2	2
Ischemia	2	2
Hemorrhage/Bleeding	2	2
High Blood Pressure/ Hypertension	2	2
Renal Impairment	2	2
Embolism/Embolus	1	1
Fever	1	1
Pulmonary Hypertension	1	1
Low Blood Pressure/ Hypotension	1	1
Unspecified Infection	1	1
Anemia	1	1
Aneurysm	1	1
Atrial Fibrillation	1	1
Bacterial Infection	1	3
Sepsis	1	1
Perforation of Esophagus	1	1
Fungal Infection	1	3
Diminished Pulse Pressure	1	1
Thromboembolism	1	3