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

Model Number	428
Health Effect - Clinical Code	No Information (3190)
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 1318694-2017-00017.
Event or Problem Description
As per the report from distributor - "as physician was preparing to inflate the inner balloon.It was determined that the stent had partially slid off the balloon.Physician realized the entire system had to be removed, the stent came completely off the balloon and was left in the descending aorta.Physician quickly moved back in with the sheath and was able to get the tip of the sheath to partially insert into the end of the stent, as the end flared a bit.Physician then came in with a snare and grabbed the sheath from the proximal end, and then moved the stent forward to the approximate target area.Next, physician inserted a 22mm balloon and successfully expanded the cp stent with perfect placement.After this step was completed it was realized that on both this case and the previous case, physician did not insert the blue insertion sleeve through the valve of the sheath.The 14f hemostasis tool provided by numed was used.Physician did not attempt to pull the stent back through the hemostasis 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.The physician did not try to pull stent back out until after it began to come off the balloon.The physician then tried to pull it back once the stent was partially off the balloon, but before the physician got to that point, the stent came completely off the balloon.".

• 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: 6669202
• Report Number: 1318694-2017-00018
• Device Sequence Number: 10966694
• 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