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

Model Number 427

Device Problem Component Falling (1105)

Patient Problem No Information (3190)

Event Date 11/23/2016

Event Type  malfunction  

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 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
• Type of Device: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 6177001
• MDR Text Key: 62844909
• Report Number: 1318694-2016-00012
• Device Sequence Number: 1
• Product Code: PNF
• UDI-Device Identifier: 04046964898921
• UDI-Public: 04046964898921
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 12 YR