WRAPSODY¿
Received Jul 28, 2026 · Event occurred Dec 5, 2024
Report 1721504-2026-00188 · MDR key 50052579
Device
Generic name
System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis
Manufacturer
Merit Medical Systems, IncCatalog number
WRAP-S07050/EUA
Lot number
H2539270
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 as evidenced by angiography revealing 70% stensosis of the proximal and distal parts of the stent. Surgical intervention through angioplasty with a high-pressure balloon. The event was considered resolved, target lesion related, probable device related, and not related to procedure.
Additional Manufacturer Narrative
The investigation is ongoing. If additional reportable information becomes available, it will be submitted in a supplemental report.