EXPRESS LD ILIAC / BILIARY
Report
- Report Number
- 2134265-2021-08546
- Event Type
- Injury
- Date Received
- July 6, 2021
- Date of Event
- June 17, 2021
- Report Date
- September 7, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIO
- UDI-DI
- 08714729392217
- PMA / PMN Number
- K133110
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
A2. AGE AT TIME OF EVENT UPDATED. B5. DESCRIBE EVENT OR PROBLEM UPDATED. H6. DEVICE CODE UPDATED.
IT WAS REPORTED THAT DEVICE MIGRATION AND SURGICAL INTERVENTION OCCURRED. THE TARGET LESION WAS LOCATED IN ARTERIAL ILIOFEMORAL. A 7.0X40X75CM EXPRESS-B-I LD STENT WAS IMPLANTED. HOWEVER, DEVICE MIGRATION OCCURRED AND SURGICAL FEMORAL CUT DOWN WAS PERFORMED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FULLLY RECOVERED. IT WAS FURTHER REPORTED VIA MEDWATCH (B)(4), THAT THE CATHETER WAS WITHIN THE LEFT COMMON FEMORAL ARTERY. WHEN IT WAS PULLED BACK, THE CATHETER TIP DETACHED.
IT WAS REPORTED THAT DEVICE MIGRATION AND SURGICAL INTERVENTION OCCURRED. THE TARGET LESION WAS LOCATED IN ARTERIAL ILIOFEMORAL. A 7.0X40X75CM EXPRESS-B-I LD STENT WAS IMPLANTED. HOWEVER, DEVICE MIGRATION OCCURRED AND SURGICAL FEMORAL CUT DOWN WAS PERFORMED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FULLY RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1020422 | EXPRESS LD ILIAC / BILIARY | STENT, ILIAC | NIO | BOSTON SCIENTIFIC CORPORATION | 20226 | 0024519564 | 08714729392217 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |