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

Model Number	427
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The detachment of the covering has been confirmed.The covering was undamaged, but returned bloody.All four glue spots were confirmed.There was minimal information available for this complaint.The distributor stated that they are unable to get more information.The stent has been flattened and the zigs are overlapped.It is unknown if the hemostasis valve tools were used for the introduction of the covered cp stent into the hemostasis valve of the introducer.The mounting procedure provided with the instructions for use specifically states that these tools are to be used for inserting the covered cp stent into the hemostasis valve of the introducer.It is likely that these tools were not used, but numed is unable to confirm this.
Event or Problem Description
As per the report from the distributor: "cover fell off when passing the hemstatic valve on the cook sheath.".

• Brand Name: COVERED CP STENT
• Common Device Name: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6177055
• Report Number: 1318694-2016-00013
• Device Sequence Number: 675224
• Product Code: PNF
• UDI-Device Identifier: 04046964898792
• UDI-Public: 04046964898792
• 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: 05/31/2021
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z28
• Device Lot Number: CCP-0686
• 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: 14 YR
• Patient Weight: 57