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

Model Number 427

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

The covered stent was returned and the stent is clean.Two adhesive spots are detached, otherwise the covering is undamaged.Four adhesive spots are visible on the covering.The stent has been crimped down.The zigs are twisted at the end of the stent where the detachment occurred.The zigs at this end of the stent are overlapped.The outer layer of glue for each of the detached adhesive spots is intact and attached to the covering.The detachment is confirmed.The zigs at the end of the stent were twisted and overlapped, which damaged the inner layer of glue for each of the detached adhesive spots, allowing the detachment to occur.This damage was caused by user handling during the crimping process.A sample from each lot of stents is tested for covering strength.The sample met the required testing strength for release of the lot.

Event Description

Covering became dislodged during mounting process.

• 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: 7439365
• MDR Text Key: 106043862
• Report Number: 1318694-2018-00004
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-0780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2017
• 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