FDA Adverse Event
Malfunction
Summary report: N
EXPRESS LD ILIAC / BILIARY
MDR report key: 21277044
·
Received January 30, 2025
Report
- Report Number
- 2124215-2025-02096
- Event Type
- Malfunction
- Date Received
- January 30, 2025
- Date of Event
- January 3, 2025
- Report Date
- February 24, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIO
- UDI-DI
- 08714729392354
- PMA / PMN Number
- K133110
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
G4 - ADDITIONAL PREMARKET / 510(K): P090003.
Additional Manufacturer Narrative · 0
G4 - ADDITIONAL PREMARKET / 510(K): P090003.
Description of Event or Problem · 0
IT WAS REPORTED THAT STENT MOVED ON BALLOON. A 9.0X60X75CM EXPRESS LD ILIAC / BILIARY STENT BALLOON EXPANDABLE WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, THE STENT MOVED ON BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT STENT MOVED ON BALLOON. A 9.0X60X75CM EXPRESS LD ILIAC / BILIARY STENT BALLOON EXPANDABLE WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, THE STENT MOVED ON BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 759579 | EXPRESS LD ILIAC / BILIARY | STENT, ILIAC | NIO | BOSTON SCIENTIFIC CORPORATION | H74938046960750 | 0032583193 | 08714729392354 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |