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

Model Number	427
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stent was returned and evaluated.The stent had been crimped down so small that the zigs at the end of the stent are overlapped (see picture attachments).One glue spot was detached.There are weak spots in the covering that appear to have been caused when the covering was pinched between the struts during crimping.This stent is only approved to be used on 12mm - 24mm balloons.Anything smaller than that can damage the stent.It is likely that the crimping of the stent down on such a small balloon led to the weak spots in the covering.A warning in the instructions for use states :"crimping the stent on a balloon catheter smaller than 12mm may cause damage to the stent.".
Event or Problem Description
As per the report from bis - "physician was crimping the stent on the balloon.After crimping, physician noticed what appeared to be some tears in the material that were not believed to be caused by the physician.The stent was removed and another stent placed.The stent was being mounted on a 10x3.5 bib.There was no difficulty mounting the stent.Crimping was done by hand.The ring mandril was not used during crimping.The stent did not slip.The slight tears in the covering of the stent were not believed to be caused by the crimping process.Contrast was being used during prep.Physician was using the product for severe coarctation of aorta.".

• Brand Name: COVERED CP STENT
• Common Device Name: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6826600
• Report Number: 1318694-2017-00025
• Device Sequence Number: 18848413
• Product Code: PNF
• UDI-Device Identifier: 04046964898907
• UDI-Public: 04046964898907
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2017

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: 03/31/2021
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z34
• Device Lot Number: CCP-0660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 20