InjuryPFV
WRAPSODY¿
Received Jul 28, 2026 · Event occurred Mar 26, 2026
Report 1721504-2026-00106 · MDR key 50052572
Device
Generic name
System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis
Manufacturer
Merit Medical Systems, IncCatalog number
WRAP-L12030
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 restenosis of the target lesion identified following fistulogram and requiring percutaneous intervention via angioplasty. The event was considered related to target lesion and not related to study device or procedure.
Additional Manufacturer Narrative
The investigation is ongoing. If additional reportable information becomes available, it will be submitted in a supplemental report.