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

Model Number 427

Device Problems Device Slipped (1584); Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 09/11/2016

Event Type  malfunction  

Manufacturer Narrative

The covering detachment was confirmed.Four adhesive spots are visible on the stent.One end of the stent has been crimped down.The root cause of this complaint cannot be determined.All covered stents are inspected in final qc to make sure that each covering has (4) acceptable glue spots.The stents are visually inspected once more after they are packaged for covering adhesion.A sample from each lot is tested for covering strength.The sample from this lot failed at 2.95 lbs, which is well above the 1.5 lb minimum required.

Event Description

(b)(4) - "intervention planned in aortic re-coarctation.Six (6) years prior treatment with stent palmaz.Failure happened during crimping of the stent on bib, the teflon came loose, thus the stent was not used.".

• 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: 6803422
• MDR Text Key: 83279829
• Report Number: 1318694-2017-00022
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2017

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: No Information
• Device Expiration Date: 05/31/2020
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-0586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• 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 Age: 15 YR
• Patient Weight: 72