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

Model Number	427
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The detachment of the covering has been confirmed.The covering is not damaged and four glue spots are visible on the covering where they were attached.The stent has been slightly flattened and is bent at the second row of welds.The zigs are overlapped, which is a sign of over crimping.It is possible that the hemostasis valve tool did not fully defeat the valve, causing the covering to detach.The mounting procedure included with the instructions for use states: "insert the leading edge of the tool into the hemostasis valve of the sheath.The tool must collapse the entire hemostasis valve to the sides of the introducer to allow the covered stent to pass." the stent was being used off-label.It is only approved for coarctation of the aorta.
Event or Problem Description
Per the report from the distributor: "cover fell off when removing the protector sheath.Used 12f protector sheath, 12f cook sheath, 14 x 4.5 bib.Mounted dry.

• Brand Name: COVERED CP STENT
• Common Device Name: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6177001
• Report Number: 1318694-2016-00012
• Device Sequence Number: 18935849
• Product Code: PNF
• UDI-Device Identifier: 04046964898921
• UDI-Public: 04046964898921
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2016

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: 01/31/2019
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-0515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2016
• Initial Report FDA Received Date: 12/15/2016
• 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