MAUDE Adverse Event Report: Merit Medical Systems Inc. WRAPSODY®; SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS

Catalog Number	WRAP-L12060
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Unintended Loss of Vascular Access (4867)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Documentation of a merit wrapsody clinical trial was received, the patient experienced thrombosis on the graft.They were treated with medication, intervention and a thrombectomy.Possibly related to the subject device.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the product history and complaint database could not be performed since the lot number was not provided.The investigation is ongoing.If additional reportable information becomes available, it will be submitted in a supplemental report.

• Brand Name: WRAPSODY®
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS
• Manufacturer (Section D): Merit Medical Systems Inc.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): Merit Medical Systems Inc.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 50854137
• Report Number: 1721504-2026-00450
• Device Sequence Number: 9651982
• Product Code: PFV
• UDI-Device Identifier: 00884450845646
• UDI-Public: 00884450845646
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P240023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: WRAP-L12060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown