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

Model Number	428
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint stent was returned in a vial and a biohazard bag.The bib portion of the device was not returned for evaluation.The covering is completely detached and bloody.There are four adhesive spots on the covering.The zigs at each end of the stent are overlapped.As per for the report from the physician / distributor - a section of a 14fr introducer was used to defeat the hemostasis valve instead of the supplied 14fr hemostasis valve tool.This may have contributed to the detachment.It is unclear if the physician used umbilical tape when the stent was "manually crimped out of the package." all covered cp stents are inspected in final qc to ensure each covering has (4) acceptable glue spots.As part of final inspection, the stent covering was tested for adhesion strength.The sample from this lot of stents had an adhesion strength of 2.41 lbs, which is well above the 1.5 lb minimum.
Event or Problem Description
As per the report from the user facility / distributor - covered mounted cp stent covering came off when inserting into the d'vill sheath.It never made it into patient.Update 9/10/2019 - in an email from the account: the d'vill was 14fr x 85cm catalog # 612845 lot #: dv-0145 st-1203; guidewire used was a.035 x 260cm lunderquist wire made by cook medical; physician did not use the blue insertion tool, but did cut off the end of a terumo sheath to use as an insertion tool, which was not saved; physician did manually crimp the stent out of the package before inserting into the sheath.

• Brand Name: COVERED MOUNTED CP STENT
• Common Device Name: AORTIC STENT SYSTEM
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 9162941
• Report Number: 1318694-2019-00020
• Device Sequence Number: 2985692
• Product Code: PNF
• UDI-Device Identifier: 04046964899430
• UDI-Public: 04046964899430
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2019

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: 07/31/2023
• Device Model Number: 428
• Device Catalogue Number: CMCP014
• Device Lot Number: CMCP-2004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1