FDA Adverse Event
Injury
Summary report: N
VICI
MDR report key: 11780652
·
Received May 5, 2021
Report
- Report Number
- 2134265-2021-05358
- Event Type
- Injury
- Date Received
- May 5, 2021
- Date of Event
- November 1, 2019
- Report Date
- May 5, 2021
- Manufacturer
- VENITI, INC.
- Product Code
- QAN
- PMA / PMN Number
- P180013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: ACTUAL EVENT DATE IS UNKNOWN. EVENT DATE APPROXIMATED BASED ON REPORT OF EVENT OCCURRING IN (B)(6) 2019.
Description of Event or Problem · 1
IT WAS REPORTED THAT STENT FRACTURE OCCURRED AND ADDITIONAL INTERVENTION WAS REQUIRED. A VICI STENT WAS IMPLANTED IN THE RIGHT SIDE GROIN AREA OF A PATIENT. MONTHS LATER, THE PATIENT RETURNED FOR A PROCEDURE ON THE LEFT SIDE. DURING A FOLLOW UP APPOINTMENT IN (B)(6) 2019, TWO FRACTURES WERE NOTED IN THE STENT ON PATIENT'S RIGHT SIDE. A NON-BOSTON SCIENTIFIC STENT WAS IMPLANTED TO COVER THE FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675313 | VICI | QAN | VENITI, INC. | 26930 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |