MAUDE Adverse Event Report: NUMED, INC. COVERED CP STENT; AORTIC STENT

Model Number 427.1

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

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

Event Date 05/25/2023

Event Type  malfunction  

Manufacturer Narrative

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 components used on the devices.All covered cp stents are inspected for proper covering attachment in final inspection.A sample from each lot is tested for covering strength.The sample from this lot failed at 2.51 lbs, well above the 1.5 lb minimum.This stent was provided unmounted, so the physcian had to crimp the device on the stent.After the stent was inserted into the introducer it was noticed that the stent was not centered on the balloon.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.".

Event Description

As per the report from the user facility / foreign distributor - the stent was not centered properly, so it was pulled off the 14f long sheath, but extracted out using a 14f tube with little resistance.When explored outside of the patient, the cover was completely separated from the stent.

• Brand Name: COVERED CP 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: 17192894
• MDR Text Key: 317785157
• Report Number: 1318694-2023-00005
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2023

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: 427.1
• Device Catalogue Number: CVRDCP8Z28
• Device Lot Number: CCP-1742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• 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: 25 YR
• Patient Sex: Male
• Patient Weight: 71 KG