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 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

The detachment of the covering was confirmed.Four adhesive spots are visible on the covering.The od of the stent when shipped is 0.181".The od of this stent is 0.114", and there is significant twisting in the zig rows at each end of the stent.As stated in the report from the hospital, they were attempting to use this device in a 9 fr.Introducer.In the instructions for use provided with the device, it states that this device when mounted on a 12mm bib required a 12 fr.Introducer.It also states in the report that they crimped this device on the bib catheter with umbilical tape.This is not the recommended method that is stated in the instructions for use.Between crimping this device with umbilical tape and trying to pass it into an introducer 3 sizes smaller than the rated introducer size, most likely caused the covering to detach.A sample from each lot of stents is tested for covering adhesion strength.The sample from this lot failed at 3.01lbs, which is well above the 1.5lb minimum acceptance criteria.

Event Description

As reported by bis "teflon cover detached from the stent.The indication the physician was using the product for: coarctation repair.The balloon the stent was mounted on: 12x4 bib.The crimping process used: crimped using umbilical tape and light finger pressure.The ring mandril was used during the crimping process.The stent did not slip.The covering became detached as the bib/stent was being advanced into the sheath using the loader provided with the stent.There was no difficulty encountered while inserting the bib/stent into the introducer.The blue introducer tool provided by numed was used.Account did not attempt to pull the stent back through the hemostasis valve.Saline media was used during prep.The balloon was not inflated.A 9f introducer sheath was used.There was nothing unusual about the patient anatomy.The catheter shaft was not kinked.The patient condition post procedure was normal"."the 12f hemostasis tool was 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: 7838037
• MDR Text Key: 119504114
• Report Number: 1318694-2018-00011
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/31/2018

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: 08/31/2022
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z39
• Device Lot Number: CCP-0802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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: 16 YR
• Patient Weight: 50