MAUDE Adverse Event Report: NUMED, INC. G-ARMOR COVERED MOUNTED STENT; AORTIC STENT

Model Number	434
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported from the user facility / distributor - "the g-ammor "tool" was too small to properly slide onto the stent and bib balloon.Only one "tool" was available in the g-armor package (614761).Also the covering was lose upon opening and was difficult to keep in place.".
Additional Manufacturer Narrative
Device was not returned and the stent remains implanted in the patient.Patient reported is good by the cath lab supervisor.Numed was unable to confirm complaint or reproduce complaint with the comparative device.The hemostasis valve tool provided with the device was the correct size and there was only supposed to be one in the package.This device is rated for a 16fr introducer, and the tool is compatible with both 16fr and 18fr devices.It is unknown as to what introducer type and size was being used by the facility.They did not provide a response to this question when asked.A comparative gcm device was pulled and tested.The comparative device was a different size balloon and lot number, but was rated for the same introducer size.The comparative device was tested with the tool it was packaged, which was a 16/18fr tool.The tool was used to defeat the valve of a 16fr cook sheath and the stent/bib combination was passed through the hemostasis tool and introducer.The gcm moved easily through both and no issues were found.The complaint could not be replicated.The distributor confirmed that this facility is not familiar with the g-armor covered mounted stent and does not routinely purchase them.

• Brand Name: G-ARMOR COVERED MOUNTED STENT
• Common Device Name: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 22123663
• Report Number: 1318694-2025-00003
• Device Sequence Number: 7483917
• Product Code: PNF
• UDI-Device Identifier: 04046955767472
• UDI-Public: 04046955767472
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 434
• Device Catalogue Number: GCM039
• Device Lot Number: GCM-0047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown