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

Model Number 428

Device Problems Fitting Problem (2183); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

The production records were reviewed for the cmcp and d'vill device.No issues were found with either of them.The cmcp was returned in a biohazard bag.A boston scientific indeflatory is attached to the cmcp outer balloon extension.The outer balloon is partially inflated.It required five full rotations of the indeflator's handle to remove all of the contrast from the balloon.The stent has been removed from the catheter.It has been completely flattened, and three of the adhesive spots are detached.The d'vill introducer was not returned.A comparative d'vill and cmcp device of equivalent sizes were pulled and tested.The comparative cmcp was the same balloon diameter as the complaint device.The comparative cmcp was passed through the proximal end of the comparative d'vill used the 14f hemostasis tool.The cmcp easily entered the sheath.The same cmcp was passed through the hemostasis valve without the hamostasis valve tool.The stent was forced off the back of the balloon as it passed through the valve.There is a statement in the instructions for use that states: "use of the tools supplied with the stent is necessary to defeat the hemostasis valve without damaging the stent or covering.Refer to insert ifu-cpce.Once the stent is past the hemostasis valve, the tool must be pulled out of the valve." it is likely that the complaint stent came off of the balloon because the hemostasis valve tool was not used when the catheter/stent combination was being inserted into the hemostasis valve of the sheath.

Event Description

As per the incident report sent to numed by the distributor - "the cp stent could not fit through the d'vill 14 french.The stent came off of the balloon.".

• Brand Name: COVERED MOUNTED 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: 8513841
• MDR Text Key: 142327326
• Report Number: 1318694-2019-00009
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 428
• Device Catalogue Number: CMCP033
• Device Lot Number: CMCP-1106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Date Manufacturer Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2015
• 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 Weight: 72