inforMED
InjuryMAF

WALLSTENT ENDOPROSTHESIS

Received Sep 2, 2025 · Event occurred Jun 29, 2025

Report 2124215-2025-61198 · MDR key 22940301

Device

Generic name

Catheter, Biliary, Diagnostic

Model number

26280

Catalog number

26280

Lot number

0033899748

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

53 YR · Female

  • Embolism/Embolus
  • Thrombosis/Thrombus
  • Embolism/Embolus
  • Thrombosis/Thrombus

Narrative

Description of Event or Problem

IT WAS REPORTED THAT EMBOLIZATION AND THROMBOSIS OCCURRED. THE PATIENT WAS ADMITTED FOR AN ILIAC VEIN EMBOLISM AND UNDERWENT MULTIPLE PROCEDURES ON (B)(6) 2025, INCLUDING INFERIOR VENA CAVA ANGIOGRAPHY, FILTER IMPLANTATION, LEFT LOWER EXTREMITY ANGIOGRAPHY, BALLOON DILATION, AND LEFT ILIAC VEIN STENT PLACEMENT. A 75CM WALLSTENT UNI WAS SELECTED FOR USED. THE PROCEDURE REVEALED LEFT ILIAC VEIN STENOSIS, AFTER BALLOON DILATION, A STENT WAS PLACED. HOWEVER, REPEATED EMBOLIZATION OF THE INFLOW TRACT CAUSED BLOOD STASIS AND THROMBOSIS. RE-INTERVENTIONAL TREATMENT, INCLUDING THROMBECTOMY, BALLOON DILATION AND CATHERIZATION THROMBOLYSIS REDUCED THE THROMBOSIS AND RESTORED BLOOD FLOW. THERE WERE NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.