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

Model Number 427

Device Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

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

Event Date 08/08/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records was performed, and no issues were noted.There are no other complaints associated with this lot number.The stent was returned for review.The covering was completely detached.4 adhesive spots are visible on the covering.The stent has been crimped down.Additional information was received from the physician / distributor.The covered cp stent had been mounted on a catheter that is not intended for stent placement.The catheter used is (2) french sizes smaller than the recommended bib catheter resulting in the stent being crimped to a smaller dimension than what is intended.When the stent is crimped on a smaller catheter, it causes the zigs to overlap, which causes it to interfere with / break the adhesive that is used to attach the covering to the stent frame.As stated in the instructions for use, the bib catheter is the device used for all testing that was performed on the covered cp stent.All covered stent are inspected at final qc wo ensure that each covering has 4 acceptable glue spots.A samples from each lot is tested for covering adhesion strength.The sample from this lot of stents had a covering adhesion strength of 2.84 lbs, which is well above the 1.5 lb minimum.

Event Description

As per the report from the user facility / distributor, this to report an incident during deployment of numed covered cp stent size cp8z34 on (b)(6) 2020.During crimping of stent on balloon, it was noted the covering on the stent is near completely detached from the metallic stent, which predisposed the covering to be completely separated inside the sheath or upon deployment in patient, so stent was not used, and returned to distributor for evaluation.

• 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: 10587612
• MDR Text Key: 208795695
• Report Number: 1318694-2020-00010
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2020

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 Expiration Date: 03/31/2023
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z34
• Device Lot Number: CCP-0862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2018
• 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