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

Model Number	427
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 7838037
• Report Number: 1318694-2018-00011
• Device Sequence Number: 19324424
• Product Code: PNF
• UDI-Device Identifier: 04046964898914
• UDI-Public: 04046964898914
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 50