TPLC - Total Product Life Cycle

• Device: aortic stent
• Definition: Coarctation of the Aorta
• Product Code: PNF
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
1	0	2	0	0	0

MDR Year	MDR Reports	MDR Events
2019	16	16
2020	7	7
2021	6	6
2022	5	5
2023	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	10	10
No Apparent Adverse Event	6	6
Device Dislodged or Dislocated	4	4
Fracture	4	4
Improper or Incorrect Procedure or Method	4	4
Device Handling Problem	3	3
Material Fragmentation	2	2
Migration or Expulsion of Device	2	2
Material Separation	2	2
Unraveled Material	1	1
Misassembled	1	1
Material Rupture	1	1
Difficult to Insert	1	1
Break	1	1
Positioning Failure	1	1
Fitting Problem	1	1
Device Damaged Prior to Use	1	1
Separation Failure	1	1
Defective Device	1	1
Malposition of Device	1	1
Patient-Device Incompatibility	1	1
Activation, Positioning or Separation Problem	1	1
Material Split, Cut or Torn	1	1
Physical Resistance/Sticking	1	1
Incomplete or Inadequate Connection	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Difficult to Advance	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	15	15
No Clinical Signs, Symptoms or Conditions	15	15
Insufficient Information	4	4
No Consequences Or Impact To Patient	2	2
Rupture	1	1
No Patient Involvement	1	1
Foreign Body In Patient	1	1
Vascular Dissection	1	1
Device Embedded In Tissue or Plaque	1	1
No Information	1	1
Failure of Implant	1	1