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

Model Number 427

Device Problem Torn Material (3024)

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

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

The covered cp stent was returned in a biohazard bag.There is contrast on the stent, so the device was taken out of the packaging and handled in some manner.There is a 1.5cm tear at one end of the stent.All four glue spots are still attached.The stent was found to be out of round from the handling.The zigs at the end of the stent where the tear occurred are overlapped (refer to pictures).The id of the stent when it returned was 0.116".The id of the stent when shipped is 0.141".The complaint is confirmed.It appears that the covering got caught between the overlapped zigs and it likely tore when an attempt was made to remove the covering from between the overlapped zigs.One covered stent is tested from every lot for covering strength.The covering strength from this lot was 2.13393 lbf, which was above the specification required for release of the lot.In the instructions for use for the covered cp stent, it tells the user when prepping the stent to "avoid unwrapping the folds in the covering.This could cause it to catch and tear off of the stent." there is also a warning that states "excessive handling and manipulation of the covering while crimping the stent may cause the covering to tear off of the stent.".

Event Description

As per the report from (b)(4): "the covering of the cp stent was torn and unusable upon removal from packaging.The stent was not used.The physician was going to use the product for stent placement in rvot prior to tpvr.No crimping was involved.The catheter shaft was not kinked.".

• 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: 7305764
• MDR Text Key: 101633275
• Report Number: 1318694-2018-00003
• Device Sequence Number: 1
• Product Code: PNF
• UDI-Device Identifier: 04046964898921
• UDI-Public: 04046964898921
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2021
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-0664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2016
• 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: 32 YR
• Patient Weight: 90