EXPRESS LD ILIAC / BILIARY
Report
- Report Number
- 2124215-2025-25072
- Event Type
- Injury
- Date Received
- May 1, 2025
- Date of Event
- March 26, 2025
- Report Date
- May 1, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIO
- UDI-DI
- 08714729579663
- PMA / PMN Number
- K133110
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4 - PREMARKET / 510(K) #: K133110, P090003.
IT WAS REPORTED THAT THE STENT DISLODGED, REQUIRING INTERVENTION. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND SEVERELY CALCIFIED OSTIAL STENOSIS OF THE CELIAC ARTERY. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY TO THE CELIAC ARTERY. A 6F NON-BOSTON SCIENTIFIC GUIDE SHEATH WAS PLACED, AND A 7.0 X 30 X 75 CM EXPRESS LD STENT BALLOON EXPANDABLE WAS ADVANCED FOR TREATMENT OVER .035 WIRE. IT WAS NOTED THAT THE GUIDE SHEATH WAS ONLY PARTIALLY INTO THE CELIAC ARTERY, AND AN ATTEMPT WAS MADE TO ADVANCE THE BALLOON/STENT OVER THE WIRE AND PAST THE LESION. HOWEVER, WHEN ADVANCING, THE BALLOON PUSHED FORWARD, CAUSING THE WIRE TO LOSE ACCESS IN THE CELIAC ARTERY, AND MOVE FORWARD IN THE AORTA. WHEN ATTEMPTING TO PULL BACK THE STENT INTO THE SHEATH, THE STENT DISLODGED FROM THE BALLOON SHAFT. A SNARE WAS USED TO PULL THE STENT BACK TO THE COMMON FEMORAL ARTERY; HOWEVER, A SURGICAL CUTDOWN WAS PERFORMED TO REMOVE THE STENT. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS UNDER LOCAL ANESTHESIA. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1023537 | EXPRESS LD ILIAC / BILIARY | STENT, ILIAC | NIO | BOSTON SCIENTIFIC CORPORATION | H74938046730750 | 0033824094 | 08714729579663 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | SHEATH: 6F TOUR GUIDE SHEATH |