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

Model Number	427
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The detached covering has been confirmed.The covering is undamaged and four glue spots are visible on the covering.The od of the stent is 0.167".The stents have an od of 0.181 when shipped from numed.It appears the covering became detached when the physician attempted to remove it from the sheath to re-crimp the stent.A special tool needs to be used to insert the stent through the hemostasis valve, so that the cover will not catch.When pulling back through the hemostasis valve, the covering will catch and detach from the stent.The od of the stent was 0.167" which is very close to the od of the stent when shipped from numed.It is likely that the stent shifted because it was not fully crimped on the balloon.This indirectly led to the covering issue since it had to be removed back through the hemostasis valve in order to re-crimp the stent on the balloon.The instructions for use states that the stent should be crimped until no movement is felt on the catheter.It also states to place a small amount of undiluted contrast to coat the stent and improve adherence to the balloon.Numed is unable to confirm whether or not this was followed.The distributor has stated that no other information is available.
Event or Problem Description
As per the report from the distributor: "during delivery, stent was found to have shifted on the bib.Then the physician tried to re-crimp the stent, the cover fell off.".

• Brand Name: COVERED CP STENT
• Common Device Name: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6177128
• Report Number: 1318694-2016-00014
• Device Sequence Number: 13465877
• Product Code: PNF
• UDI-Device Identifier: 04046964898792
• UDI-Public: 04046964898792
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2016

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: Physician
• Device Expiration Date: 05/31/2020
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z28
• Device Lot Number: CCP-0592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2016
• Initial Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 50