MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. WRAPSODY¿; MERIT WRAPSODY¿.ENDOPROSTHESIS.16 MM.40 MM.120 CM.14F.12.7 MM - 14.4 MM.0.035" (

Catalog Number	WRAP-L16040/EUA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up will be submitted when the evaluation is complete.
Event or Problem Description
During deployment of the stent, the white plastic component at the distal end of the application device detached from the application device.A snare was used to successfully remove the compnent.No injury to the patient was reported.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: WRAPSODY¿
• Common Device Name: MERIT WRAPSODY¿.ENDOPROSTHESIS.16 MM.40 MM.120 CM.14F.12.7 MM - 14.4 MM.0.035" (
• 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: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22868730
• Report Number: 1721504-2025-00284
• Device Sequence Number: 7732710
• Product Code: PFV
• UDI-Device Identifier: 00884450845493
• UDI-Public: 00884450845493
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: WRAP-L16040/EUA
• Device Lot Number: H2837708
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown