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	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of the complaint cannot be positively determined since the device was implanted in the patient and not returned.Films of the procedure were sent to numed to review but did not include videos of when the sheath was actually retracted and the stent fully exposed before inflation.The film skipped over that part of it and just showed the stent once the inner balloon had already been inflated.The stent was able to be used and the patient was fine post procedure.
Event or Problem Description
As per the report from bis: "the stent went through the sheath fine.After unsheathing, it was noticed that the stent was mounted distally before inflation, it had migrated.The physician was about to use the stent, it was just difficult to use.The stent was being used for a small conduit tear.An inflation device with pressure gauge was used.The catheter shaft was not kinked.There was nothing unusual about the patient anatomy.The patient was fine post procedure.Saline and contrast were both used during prep.The physician did inflate the inner balloon before the outer balloon, and did not attempt to pull the stent back through the hemostasis valve at any time.".

• 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: 6347045
• Report Number: 1318694-2017-00006
• Device Sequence Number: 1200715
• Product Code: PNF
• UDI-Device Identifier: 04046964899553
• UDI-Public: 04046964899553
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

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: 10/31/2021
• Device Model Number: 428
• Device Catalogue Number: CMCP026
• Device Lot Number: CMCP-1429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Initial Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 51