WRAPSODY¿
Received Jul 28, 2026 · Event occurred Jun 13, 2024
Report 1721504-2026-00190 · MDR key 50052589
Device
Generic name
System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis
Manufacturer
Merit Medical Systems, IncCatalog number
WRAP-L08125/EUA
Lot number
H2745561
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Thrombosis/Thrombus
Narrative
Description of Event or Problem
It was reported via clinical trial that a patient experienced moderate thrombosis resulting in hopsitalization and surgery. The patient chose to abdandon the site access and undergo implantation of a long-term catheter. The event is considered resolved, possible device related, not procedure related or target related.
Additional Manufacturer Narrative
The investigation is ongoing. If additional reportable information becomes available, it will be submitted in a supplemental report.