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

Model Number	428
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record was performed and no issues were noted.There are no other complaints associated with this lot number.The complaint device was not returned, but the dislodgement of the stent and tear in the covering most likely occurred because the instructions for use were not followed.The hemostasis tool was not used when the stent was passed through the hemostasis valve, making stent migration highly likely.The tear in the covering most likely occurred either as the stent was being pushed or pulled through the hemostasis valve.The ifu states "use of the tools supplied with the stent is necessary to defeat the hemostasis valve without damaging the stent or covering.Once the stent is past the hemostasis valve, the tool must be pulled out of the valve." the user facility stated that they did not use the tools provided and had trouble passing the stent-catheter combination through the check flow valve.The insertion without the tools caused the stent to move on the balloon and also damaged the covering.
Event or Problem Description
As per the report from the distributor / user facility - 14 fr d'vill sheath in rvot, lunderquist wire, difficulty passing the balloon stent combo though the check flow valve, without protector.Before the stent balloon combo exited the distal end of the sheath, a mal-position of the stent on the balloon was noted.The stent balloon combo was removed from the sheath uneventfully, although a slight damage goretex on the distal end of the stent was noted.On the back table the balloon used to expand the stent resulted in further tear of goretex with only about 1/3 of the stent covered after expansion.The indication the physician was using the product for was conduit rehabilitation prior to tpvr.The blue introducer tool provided by numed was not used.There was an attempt to pull the stent back through the hemostasis valve.Neither balloon was inflated in the patient, on the back table the inner was inflated first.The catheter shaft was not kinked.

• Brand Name: COVERED MOUNTED CP STENT
• Common Device Name: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 11466588
• Report Number: 1318694-2021-00003
• Device Sequence Number: 4498473
• Product Code: PNF
• UDI-Device Identifier: 04046964899515
• UDI-Public: 04046964899515
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

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: No Information
• Device Expiration Date: 12/31/2024
• Device Model Number: 428
• Device Catalogue Number: CMCP022
• Device Lot Number: CMCP-2603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1