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 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

The stent has not been returned to numed for evaluation.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 stent had a covering attachment strength of 2.53lbs, 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.If the device is returned and evaluated, and it results in additional information for this mdr, a follow-up report will be sent.

Event Description

As reported by the distributor / user facility - the sleeve just came off the stent.I introduced the cp covered stent the way i always introduce it, but it was somewhat difficult to get through the 14fr d'vill sheath.The stent was on an 18mm bib and it should have gone without a snag.We redid it with a different cp stent and everything went great and no snags, so i don't know if there was something with the sleeve itself but the sleeve completely came off.The indication the physician was using the product for was coarctation of the aorta.There was no difficulty mounting the stent.The covering came completely off when being introduced into the 14fr d'vill.(b)(6) 2020 - in an email from the account: only saline was used during the prep.Physician hand mounted in the usual way and used the enclosed sleeve to introduce through the valve of the d'vill sheath.Instructions for use and mounting procedure were followed.The 14fr introducer included in the packet with the cp covered stent was used.With introduction of the stent/balloon complex physician felt resistance going through the d'vill sheath.Physician did not feel comfortable pushing any further and therefore removed the complex and noted that the covering was completely off of the stent with the stent being firmly positioned on the balloon and had not migrated at all.

• Brand Name: COVERED CP STENT
• Type of Device: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton, ny
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton, ny
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, ny ; 3284491
• MDR Report Key: 9744204
• MDR Text Key: 190800927
• Report Number: 1318694-2020-00004
• Device Sequence Number: 1
• Product Code: PNF
• UDI-Device Identifier: 04046964898921
• UDI-Public: 04046964898921
• 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,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2020

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: 02/28/2024
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-0990
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• 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: 21 YR
• Patient Weight: 63