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	08/05/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 8961013
• Report Number: 1318694-2019-00018
• Device Sequence Number: 13963537
• Product Code: PNF
• UDI-Device Identifier: 04046964898914
• UDI-Public: 04046964898914
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Weight: 51