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

Model Number	428
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was implanted and not returned to numed.The hemostasis valve tools were not fully inserted in either case, which would cause the stent to catch on the hemostasis valve.This is most likely the cause of the stent migration/dislodgement.This complaint involved two cmcp-1558.Same physician, same hospital, two different patients on the same day.The second report is number 1318694-2017-00018.Device implanted and not returned.
Event or Problem Description
As per the report from distributor - "after unsheathing the stent in the desired location and the inner balloon was inflated, it was determined that the stent had partially slid off the balloon.The doctor was able to partially inflate the outer balloon, deflate, move, and properly expand the remainder of the stent.The end result was perfect placement and the gradient was no longer present.Saline was used during prep.The 14f hemostasis tool provided by numed was used.Physician did not attempt to pull the stent back through the neostasis valve at any time." clarification from bis specialist - sent on 6/22/2017 - "the physician did use the tools provided by numed, however, the physician did not insert the insertion sleeve far enough.".

• Brand Name: COVERED AND MOUNTED CP STENT
• Common Device Name: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6669198
• Report Number: 1318694-2017-00017
• Device Sequence Number: 72178
• Product Code: PNF
• UDI-Device Identifier: 04046964899560
• UDI-Public: 04046964899560
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2017

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: Physician
• Device Expiration Date: 03/31/2022
• Device Model Number: 428
• Device Catalogue Number: CMCP027
• Device Lot Number: CMCP-1558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1