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

Model Number 427

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint stent was returned in a biohazard bag.There is blood on the covering and three adhesive spots are detached.One end of the stent has been flattened and the zigs at this end of the stent are overlapped.This was likely the result of removing a partially crimped stent from the balloon.Four adhesive spots are visible on the covering.The complaint is confirmed.The root cause of the complaint cannot be determined.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 of stents had a covering attachment strength of 2.79lbs, which is well above the minimum specification.There is a warning in the ifu 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 the hospital / distributor - the sleeve detached and began to slip off the stent when crimping onto the bib.The indication the physician was using the product for: coarctation of the aorta.The balloon the stent was being mounted on: bb033.They did not completely mount the stent due to the sleeve separating from the stent.They placed another cp stent with success.The standard process of crimping was used.The blue introducer tool provided by numed was not used.They did not attempt to pull the stent back through the hemostasis valve at any time.Saline was used during prep.There was nothing unusual about the patient anatomy.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: 8961013
• MDR Text Key: 200824429
• Report Number: 1318694-2019-00018
• Device Sequence Number: 1
• Product Code: PNF
• UDI-Device Identifier: 04046964898914
• UDI-Public: 04046964898914
• 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,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2019

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: 04/30/2021
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z39
• Device Lot Number: CCP-0680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2016
• 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: 12 YR
• Patient Weight: 51