EXPRESS LD ILIAC / BILIARY
Report
- Report Number
- 2124215-2026-01261
- Event Type
- Malfunction
- Date Received
- January 8, 2026
- Date of Event
- December 16, 2025
- Report Date
- February 10, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIO
- UDI-DI
- 08714729392507
- PMA / PMN Number
- K133110
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H6 - EVALUATION METHOD CODES: UPDATED. H6 - EVALUATION CONCLUSION CODES: UPDATED. G4 - PREMARKET / 510(K) #: K133110, P0900030.
G4 - PREMARKET / 510(K) #: K133110, P090003.
IT WAS REPORTED THAT A SMALL HOLE IN THE PACKAGING OCCURRED. A 9.0X40X135 CM EXPRESS LD STENT BALLOON EXPANDABLE WAS SELECTED FOR USE. UPON OPENING THE DEVICE, A SMALL HOLE WAS NOTICED IN THE OUTER PACKAGING, WHICH COMPROMISED THE STERILITY OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT A SMALL HOLE IN THE PACKAGING OCCURRED. A 9.0X40X135 CM EXPRESS LD STENT BALLOON EXPANDABLE WAS SELECTED FOR USE. UPON OPENING THE DEVICE, A SMALL HOLE WAS NOTICED IN THE OUTER PACKAGING, WHICH COMPROMISED THE STERILITY OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390708 | EXPRESS LD ILIAC / BILIARY | STENT, ILIAC | NIO | BOSTON SCIENTIFIC CORPORATION | H74938047940130 | 0033871874 | 08714729392507 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male |