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

Model Number 432

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

This device was a compassionate use device under approval u220486.The marketing approval for regular sizes is p150028 - g-armor covered stent.The compassionate use was for a device not included in the marketing approval.It was a longer g-armor covered stent (8.4cm) with only a partial covering.The device was not returned to numed for review and investigation.The production traveler (dhr) was reviewed and no issues were found.All devices in this lot met the criteria for release and distribution.There are no other associated complaints with this lot of devices or with the associate covering component.As per the follow up report from the physician the patient returned to pacu in good condition.There was no observable clinical symptoms or change in symptoms identified with the patient noted in the report.No apparent harm occurred in relation to the covering.As noted in the report from the physician, the introducer chosen was not long enough to get to the location of the stent placement.The physician attempted to pull the covered stent back into introducer, which is a known risk for covering detachments.There is a specific warning in the instructions for use that states: "pulling the covered stent back through the introducer and/or hemostasis valve may cause the covering to catch and tear off of the stent." user facility report number was (b)(4).The cath.Report from this procedure is being sent to the fda - cdrh - ode as part of the compassionate use (u220486) follow-up documentation.So this will be reported to them as well.This was sent via ups on 01/17/2023.

Event Description

Stent covering dislodged.

• Brand Name: G-ARMOR COVERED STENT
• Type of Device: 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: 16184373
• MDR Text Key: 307508841
• Report Number: 1318694-2023-00001
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2023

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 Operator: Health Professional
• Device Model Number: 432
• Device Catalogue Number: CUSTOM111
• Device Lot Number: EER-8881
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 116 KG