InjuryPFV
WRAPSODY¿
Received Jul 28, 2026 · Event occurred Feb 15, 2026
Report 1721504-2026-00187 · MDR key 50052593
Device
Generic name
System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis
Manufacturer
Merit Medical Systems, IncCatalog number
WRAP-S08050
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Restenosis
Narrative
Description of Event or Problem
It was reported via clinical trial that a patient experienced severe restenosis of the non-target lesion due to a new stenosis distal to the Wrapsody stent, requiring surgical and percutaenous intervention. The event was considered resolved, not related to procedure or target lesion, and possible related to device.
Additional Manufacturer Narrative
The investigation is ongoing. If additional reportable information becomes available, it will be submitted in a supplemental report.