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

Model Number	427
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device has not been returned to numed for evaluation.From the report given to numed by the user facility, it stated that the physician inserted the device and then removed from the body to reposition.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." this is likely what happened in this instance to cause the covering to loosen from the stent.
Event or Problem Description
As per the report from (b)(6): "physician went into the body with the unmounted stent on a bib balloon, and removed the stent from the body to reposition.It was then noticed that the covering was starting to come off the stent.Physician decided not to re-enter the body with this stent, then opened a pre mounted cp stent in the same size which was deployed without incident.".

• Brand Name: COVERED CP STENT
• Common Device Name: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6311655
• Report Number: 1318694-2017-00004
• Device Sequence Number: 1159774
• Product Code: PNF
• UDI-Device Identifier: 04046964898921
• UDI-Public: 04046964898921
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2017

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
• Operator of Device: No Information
• Device Expiration Date: 02/28/2021
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-0658
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Weight: 58