TPLC - Total Product Life Cycle

• Device: stent graft, bypass, superficial femoral artery
• Definition: For bypassing stenosis in the superficial femoral artery via the femoral vein
• Product Code: QWM
• Device Class: 3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
0	0	2	1	5	1

MDR Year	MDR Reports	MDR Events
2023	1	1
2024	16	16
2025	8	8
2026	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Migration	6	6
Device Stenosis	5	5
Complete Blockage	5	5
Migration or Expulsion of Device	3	3
Malposition of Device	3	3
Unintended Movement	3	3
Obstruction of Flow	3	3
Activation Failure	3	3
Difficult to Advance	2	2
Difficult to Remove	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Failure to Unfold or Unwrap	2	2
Noise, Audible	2	2
Activation, Positioning or Separation Problem	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Difficult or Delayed Activation	1	1
Insufficient Device Problem Information	1	1
Lack of Effect	1	1
Material Deformation	1	1
Partial Blockage	1	1
Detachment of Device or Device Component	1	1
Failure to Advance	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Obstruction/Occlusion	12	12
No Clinical Signs, Symptoms or Conditions	10	10
Pain	8	8
Thrombosis/Thrombus	5	5
Ischemia	3	3
Failure of Implant	2	2
Insufficient Information	2	2
Stenosis	2	2
Sepsis	1	1
Necrosis	1	1
Vascular Dissection	1	1
Exsanguination	1	1
Hematoma	1	1
Retroperitoneal Hemorrhage	1	1
Bacterial Infection	1	1
Respiratory Failure	1	1
Fistula	1	1