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

Model Number 428

Device Problems Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2017

Event Type  malfunction  

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 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
• 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: 6669198
• MDR Text Key: 78608480
• Report Number: 1318694-2017-00017
• Device Sequence Number: 1
• Product Code: PNF
• UDI-Device Identifier: 04046964899560
• UDI-Public: 04046964899560
• 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: Other
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• 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