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

Model Number 427

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The stent was returned in the bottle, pouches and box.The stent and covering are clean.The covering is completely detached.There are four (4) adhesive spots on the covering.The covering is not damaged and the folds are still present.The stent has been crimped down.The od of the stent measures 0.150" and the zigs at each end of the stent are severly overlapped.Upon product release at numed, the stent od measures 0.181".Detachment is confirmed.It is probable that the overlapped zigs caused the adhesive spots to come loose.An improper crimping technique was being used.Numed has both mounting videos for physicians showing them the proper technique for crimping the stent, as well as step by step pictorials that are sent with each stent that is not pre-mounted.The mounting process was not followed by the physician.Sample from each lot is tested for covering pull strength.This sample met the acceptance criteria of a minimum of 1.5 lbf.This sample had a pull strength of 2.45 lbf.

Event Description

As per report by foreign user facility: "the covering has come off.Failure detected before application.No impact on patient, user or third person.".

• 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: melissa thomas ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 6604968
• MDR Text Key: 76728571
• Report Number: 1318694-2017-00015
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2017

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
• Device Operator: Physician
• Device Expiration Date: 03/31/2020
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-0581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• 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