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

Model Number	427
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was returned in its vial.The stent is bloody.All four glue spots are visible on the covering.Two glue spots are detached from the stent frame.The root cause of the detachment cannot be confirmed.The stent and covering appear to be normal other than the detached glue spots.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 1.78lbs, 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.
Event or Problem Description
As per the report from the user facility / distributor: physician was prepping and the stent covering came off of the stent, the covering peeled off.Physician used another cp stent the exact same size and it worked perfectly.Physician stated that this has never happened before.The product is saved in the tube.The size of the balloon the stent was mounted on: bib 16x3.Physician barely began to crimp and the covering came off of the stent.The ring mandril was used during the crimping process.The covering came off before it could be used.Physician is a long time cp stent customer.

• Brand Name: COVERED CP STENT
• Common Device Name: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 12108329
• Report Number: 1318694-2021-00005
• Device Sequence Number: 17309375
• Product Code: PNF
• UDI-Device Identifier: 04046964898792
• UDI-Public: 04046964898792
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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: 05/31/2023
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z28
• Device Lot Number: CCP-0885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1