EXPRESS LD ILIAC / BILIARY
Report
- Report Number
- 2124215-2025-53149
- Event Type
- Injury
- Date Received
- August 6, 2025
- Date of Event
- July 8, 2025
- Report Date
- December 4, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIO
- UDI-DI
- 08714729392514
- PMA / PMN Number
- K133110
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PREMARKET / 510(K) #: K133110, P090003.
E1 - UPDATED INITIAL REPORTER ZIP/POST CODE. PREMARKET / 510(K) #: K133110, P090003. DEVICE EVALUATED BY MFR: THE EXPRESS LD WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THAT THE BALLOON WAS NOT FOLDED AND WAS SUBJECTED TO POSITIVE PRESSURE. LIQUID NOTED INSIDE BALLOON. A VISUAL EXAMINATION IDENTIFIED THAT THE DEVICE WAS RECEIVED WITH THE STENT ALREADY DETACHED FROM THE BALLOON MATERIAL. THE DETACHED STENT WAS NOT RETURNED WITH THE DEVICE. NO ISSUES WERE NOTED WITH THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES ALONG THE LENGTH OF THE DEVICE.
PREMARKET / 510(K) #: K133110, P090003.
PREMARKET / 510(K) #: K133110, P090003. DEVICE EVALUATED BY MFR: THE EXPRESS LD WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THAT THE BALLOON WAS NOT FOLDED AND WAS SUBJECTED TO POSITIVE PRESSURE. LIQUID NOTED INSIDE BALLOON. A VISUAL EXAMINATION IDENTIFIED THAT THE DEVICE WAS RECEIVED WITH THE STENT ALREADY DETACHED FROM THE BALLOON MATERIAL. THE DETACHED STENT WAS NOT RETURNED WITH THE DEVICE. NO ISSUES WERE NOTED WITH THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES ALONG THE LENGTH OF THE DEVICE.
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 9.0X60X135 CM EXPRESS LD STENT BALLOON WAS SELECTED FOR PROCEDURE. DURING THE PROCEDURE, THE STENT UNINTENTIONALLY DISLODGED BEFORE REACHING THE LESION. THE PHYSICIAN THEN RELEASED THE STENT AT ITS CURRENT LOCATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 9.0X60X135 CM EXPRESS LD STENT BALLOON WAS SELECTED FOR PROCEDURE. DURING THE PROCEDURE, THE STENT UNINTENTIONALLY DISLODGED BEFORE REACHING THE LESION. THE PHYSICIAN THEN RELEASED THE STENT AT ITS CURRENT LOCATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE STENT WAS NOT REMOVED AND A MUSTANG BALLOON WAS USED TO TREAT THE LESION. THE EXPRESS LD WAS RETURNED FOR ANALYSIS AND INVESTIGATION WAS COMPLETED ON 01SEP2025. A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THAT THE BALLOON WAS NOT FOLDED AND WAS SUBJECTED TO POSITIVE PRESSURE. LIQUID NOTED INSIDE BALLOON. A VISUAL EXAMINATION IDENTIFIED THAT THE DEVICE WAS RECEIVED WITH THE STENT ALREADY DETACHED FROM THE BALLOON MATERIAL. THE DETACHED STENT WAS NOT RETURNED WITH THE DEVICE. NO ISSUES WERE NOTED WITH THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES ALONG THE LENGTH OF THE DEVICE.
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 9.0X60X135 CM EXPRESS LD STENT BALLOON WAS SELECTED FOR PROCEDURE. DURING THE PROCEDURE, THE STENT UNINTENTIONALLY DISLODGED BEFORE REACHING THE LESION. THE PHYSICIAN THEN RELEASED THE STENT AT ITS CURRENT LOCATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE STENT WAS NOT REMOVED AND A MUSTANG BALLOON WAS USED TO TREAT THE LESION.
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 9.0X60X135 CM EXPRESS LD STENT BALLOON WAS SELECTED FOR PROCEDURE. DURING THE PROCEDURE, THE STENT UNINTENTIONALLY DISLODGED BEFORE REACHING THE LESION. THE PHYSICIAN THEN RELEASED THE STENT AT ITS CURRENT LOCATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE STENT WAS NOT REMOVED AND A MUSTANG BALLOON WAS USED TO TREAT THE LESION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1725983 | EXPRESS LD ILIAC / BILIARY | STENT, ILIAC | NIO | BOSTON SCIENTIFIC CORPORATION | H74938047960130 | 0034345179 | 08714729392514 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |