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

Model Number	428.1
Medical Device Problem Codes	Difficult to Insert (1316); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or with the components used on the devices.The d'vill introducer that the device was being used with was not returned for evaluation, so it was unable to be determined what cause the stent to become dislodged within the sheath.The complaint stent and bib were returned to numed for investigation.The stent is no longer crimped down on the bib.The covering was completely detached from the stent and not returned.The stent has been flattened at one end.The od of the stent at the flattened end is 0.194" at its widest point and 0.108" at its narrowest point.The other end of the stent had an od of 0.143".The id of the 12fr introducer is 0.154".It is unknown as to when the stent became flattened, before or after removal from the sheath.The zigs at each end of the stent were overlapped.The condition of the stent and the lack of access to the introducer used during the procedure make it impossible to recreate the complaint.
Event or Problem Description
As per the report from the user facility / distributor - mounted covered cp would not go through a 12 fr d'vill introducer.It got stuck in the sheath and came off the shaft.Dr.Kanter cut the d'vill to try to salvage the cp but it was too damaged to be used.

• Brand Name: COVERED MOUNTED CP STENT
• Common Device Name: 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: 17192311
• Report Number: 1318694-2023-00004
• Device Sequence Number: 20254017
• Product Code: PNF
• UDI-Device Identifier: 04046964899478
• UDI-Public: 04046964899478
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2023

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: 05/31/2026
• Device Model Number: 428.1
• Device Catalogue Number: CMCP018
• Device Lot Number: CMCP-3315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Male