Express LD Vascular
Received Jul 27, 2026 · Event occurred Jun 30, 2026
Report 2124215-2026-40138 · MDR key 50045713
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
20212Catalog number
20212
Lot number
0036971404
Product problems
- Deformation Due to Compressive Stress
- Material Deformation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the stent was structurally damaged. A 7.0 x 40 x 135 cm Express Vascular LD Stent was selected for treatment. During the procedure, the stent was introduced and advanced toward the target lesion. Prior to reaching the lesion site, the device encountered vessel tortuosity and became bent. The stent was subsequently withdrawn for evaluation and was observed to be structurally damaged. The procedure was completed using another of same device. No patient complications or adverse effects were reported as a result of the event.