MalfunctionNIP
Pulsar-18 T3 5/60/90
Received Jul 29, 2026 · Event occurred Jul 7, 2026
Report 8043892-2026-07142 · MDR key 50067765
Device
Generic name
Stent, Superficial Femoral Artery
Manufacturer
Biotronik AgModel number
430450Lot number
04263112
Product problems
- Fracture
- Premature Activation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The Pulsar-18 T3 self-expandable peripheral stent system was selected for treatment below the knee. While advancing the device through the 4F introducer sheath into the vessel, resistance was encountered inside the introducer sheath. This resulted in premature deployment of the stent within the introducer sheath. A small surgical incision was required to remove several stent fragments from the subcutaneous tissue.