MalfunctionPRL
ICAST COVERED STENT SYSTEM, 5MMX22MMX80CM
Received Jul 2, 2026 · Event occurred Jun 4, 2026
Report 3011175548-2026-000007 · MDR key 25689615
Device
Generic name
Iliac Covered Stent, Arterial
Manufacturer
Atrium Medical CorporationModel number
48522Catalog number
48522
Lot number
529552
Product problems
- Material Twisted/Bent
Patient
72 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DUE TO CHARACTER RESTRICTIONS IN BLOCK E1: EVENT SITE NAME: (B)(6) HOSPITAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT TIP OF THE ICAST STENT WAS FOUND TO BE BENT DURING USE. NO HARM WAS REPORTED.