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

Model Number 427

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

There was no patient contact with this device.The malfunction occurred during the mounting process and did not involve contact with the patient.The stent was returned in a vial.It stent was clean.The covering is completely detached from the stent.Four glue spots are visible on the covering.The covering is intact and is not damaged.The stent has been crimped.The od of the stent is 0.160".Stents have an od of 0.181" when they are shipped from numed.The zigs have not been twisted.The adhesive used on this lot was reviewed and within the expiration date.A sample from every lot of stents is tested for covering adhesion strength as part of the final inspection process.The sample from this lot failed at 4.31 lbf which is above the acceptance criteria of 1.5 lbs.The root cause of the detachment cannot be determined.

Event Description

As reported to numed by the user facility / distributor - cover displaced from cp stent - cp stent was mounted on a dry bib balloon by a long-time numed user.User was cautious to use fresh, dry gloves and to avoid twisting motions during mounting due to past experience and specific instructions from pgm and numed.Despite precautions, the covering still came loose 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: 8056257
• MDR Text Key: 128032255
• Report Number: 1318694-2018-00013
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2018

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: 06/30/2019
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z39
• Device Lot Number: CCP-0531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2014
• 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