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

Model Number	428
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The production traveler (device history record) 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.The device was implanted in the patient without the covering, so it was not able to be returned for evaluation.All covered cp stents are inspected at final qc to ensure each covering has (4) acceptable glue spots.As part of final inspection, one stent from each lot of devices is tested for stent covering adhesion strength.The stent from this lot had an adhesion strength of 2.52 lbs, which is well above the minimum requirement of 1.5 lbs.As per the report from the user facility / distributor, the blue hemostasis valve tool was not used to defeat the hemostasis valve of the sheath when being inserted into the introducer.The covered mounted cp stent ifu has a warning that states: "use of 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 stent was also pulled back through the hemostasis valve during the procedure when the physician thought that the covering was detaching from the stent.There is an additional warning in the ifu that states: "pulling the covered stent back through the introducer and/or hemostasis valve may cause the covering to catch and tear off of the stent." it is unknown if the covering detached due to the lack of use of the provided hemostasis valve tools or if it detached when pulled back into the sheath.
Event or Problem Description
As per the report from the distributor / user facility - "when trying to deploy, some of the outer coating started to come off.Physician managed to remove the rest of it, and keep the stent in place.Implant was used for placing, to make a stable landing zone for possible transcatheter valve placement.The stent did not slip.There was no difficulty while inserting the bib/stent into the introducer.The blue introducer tool provided by numed was not used.They did not attempt to pull the stent back through the hemostasis valve at any time.Contrast was used in the balloon to visualize and saline was used to wipe the exchange wire.An inflation device with pressure gauge was used.The introducer sheath used was 18fr 85cm length.The catheter shaft was not kinked.There was nothing unusual about the patient anatomy.The patient's condition post procedure was good." the stent was placed without the covering.

• 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: 9402043
• Report Number: 1318694-2019-00024
• Device Sequence Number: 2677021
• Product Code: PNF
• UDI-Device Identifier: 04046955091829
• UDI-Public: 04046955091829
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

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: 06/30/2023
• Device Model Number: 428
• Device Catalogue Number: CMCP058
• Device Lot Number: CMCP-1991
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 41