FDA Adverse Event
Malfunction
Summary report: N
LIMFLOW EXTENSION STENT GRAFT, 5.5MM X 200MM
MDR report key: 25114198
·
Received May 7, 2026
Report
- Report Number
- 3023527320-2026-00001
- Event Type
- Malfunction
- Date Received
- May 7, 2026
- Date of Event
- April 7, 2026
- Report Date
- May 7, 2026
- Manufacturer
- INARI MEDICAL, INC.
- Product Code
- QWN
- UDI-DI
- 00850041730219
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
MANUFACTURER REFERENCE NUMBER: (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
ON (B)(6) 2026, A PATIENT UNDERWENT A PROCEDURE USING THE LIMFLOW SYSTEM OF DEVICES. THE PROCEDURE PROGRESSED SUCCESSFULLY TO STENT DEPLOYMENT. AFTERWARD IT WAS FOUND THAT A PIECE OF THE CATHETER HAD BROKEN OFF INTO THE PATIENT. THE SURGEON WAS ABLE TO REMOVE IT AND COMPLETED THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328709 | LIMFLOW EXTENSION STENT GRAFT, 5.5MM X 200MM | STENT GRAFT, INFRAPOPLITEAL, VENOUS ARTERIALIZATION | QWN | INARI MEDICAL, INC. | RGS | 82343334 | 00850041730219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |