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

Model Number 427

Device Problems No Apparent Adverse Event (3189); Device Handling Problem (3265)

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

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record was performed and no issues were noted.There are no other complaints associated with this lot number.A review of the component lot numbers used to manufacture this lot of stents was also reviewed and no other complaints were found.All covered stents are tested at final qc to ensure that each covering has (4) acceptable glue spots.A sample from each lot is tested for covering adhesion strength.The sample from this lot had a covering adhesion strength of 3.2 lbs, which is well above the 1.5 lb minimum.The complaint stent was returned and evaluated.There is contrast on the stent.Two adhesive spots are detached, otherwise the covering is intact.The stent is flattened on one end and is bent.As per the instructions for use, the physician should "always place an appropriate sized guidewire or mandrel through the balloon catheter guidewire lumen while prepping the balloon and crimping the stent." the report from the user facility stated that the mandrel was not used.The ifu states: "always place an appropriate sized guidewire or mandrel through the balloon catheter guidewire lumen while prepping the balloon and crimping the stent." "the rolling action should be done in the same direction as the folds in the covering.Avoid unwrapping the folds in the covering.This could cause it to catch and tear off of the stent.".

Event Description

As reported to numed by the distributor / user facility - while crimping the stent onto a 24x4 bib the physician noticed that the proximal end of the covering was sliding off the stent.The indication the physician as using the product for: intimal tear in rv-pa conduit.There was no difficulty mounting the stent.Crimping was manual, by hand.The ring mandril was not used during the crimping process.The stent was not used on the patient.The blue introducer tool provided by numed was not used.They did not attempt to pull the stent back through the hemostasis valve at any time.Contrast media was used during prep.The balloon was not inflated, no introducer sheath was used.The catheter shaft was not kinked.

• 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: 10828360
• MDR Text Key: 231999819
• Report Number: 1318694-2020-00012
• Device Sequence Number: 1
• Product Code: PNF
• UDI-Device Identifier: 04046964898921
• UDI-Public: 04046964898921
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/12/2020

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
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2019
• 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: 26 YR
• Patient Weight: 62