FDA Adverse Event
Malfunction
Summary report: N
PULSAR-18 T3 5/150/135
MDR report key: 25015169
·
Received April 28, 2026
Report
- Report Number
- 8043892-2026-04032
- Event Type
- Malfunction
- Date Received
- April 28, 2026
- Date of Event
- January 18, 2026
- Report Date
- April 28, 2026
- Manufacturer
- BIOTRONIK AG
- Product Code
- NIP
- UDI-DI
- 07640130446922
- PMA / PMN Number
- P160025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (95% STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE MID FEMORAL ARTERY. AFTER PRE-DILATATION OF THE LESION, STENT IMPLANTATION WAS PERFORMED. FIRST, A PULSAR-18 T3 5/170/135 STENT WAS IMPLANTED VIA THE SUPERFICIAL FEMORAL ARTERY AND SUCCESSFULLY RELEASED. SUBSEQUENTLY, THE COMPLAINT DEVICE WAS PLACED BUT FAILED TO RELEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405100 | PULSAR-18 T3 5/150/135 | STENT, SUPERFICIAL FEMORAL ARTERY | NIP | BIOTRONIK AG | 430494 | 07252892 | 07640130446922 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |