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

Model Number 427

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned in its shelf carton and outer pouch.There is contrast on the stent.The covering is completely detached.Four adhesive spots are visible on the stent.There is a 4mm tear at one glue spot.The stent has been flattened at one end.This likely occurred when the stent was removed from the bib.The zigs at the other end of the stent are overlapped.This end has an od of 0.155".The overlapped zigs occured during crimping.The average od of the device at final release is 0.218".The overlapped zigs contributed to the detachment.The ifu contains 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." all covered cp stents are inspected for proper covering attachment in final inspection.A sample from each lot is tested for covering attachment strength.The sample from this lot had a covering attachment strength of 2.68lbs, which is above the minimum specification.The production traveler (dhr) was reviewed and no issues were found.All devices in this lot met the criteria for release and distribution.There are no other associated complaints with this lot of devices.A review was performed on the component lots used for the manufacturing of this lot of devices.There were no other associated complaints with the components used; glue and eptfe.

Event Description

As per report by foreign user facility : "after removal of the product from the package, the stent patch did not adhere to the stent.Patch came off stent completely when mounted on bib.Another stent was used.".

• Brand Name: COVERED CP STENT
• Type of Device: 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: 12274030
• MDR Text Key: 267041845
• Report Number: 1318694-2021-00006
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 08/04/2021

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: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z34
• Device Lot Number: CCP-0806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2017
• 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: 15 YR
• Patient Weight: 75