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

Model Number 428

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2021

Event Type  malfunction  

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.A review of the component lot numbers used to manufacture this lot was also reviewed and no other complaints were found.The cmcp device was returned and evaluated.The covering was completely detached from the stent frame.The stent has shifted to the distal end of the balloon.Two of the zigs at the proximal end are completely folded over (see pictures).All other zigs appear normal.The proximal position of the bent zigs make it likely that this was caused by pulling the stent back into the hemostasis valve during the procedure.The detached covering probably occurred for the same reason.All mounted stents are visually inspected for defects in final qc before being released for distribution.There is a warning in the instructions for use 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." there is also a precaution that states; "stents are delicate devices.Care should be exercised while handling to help prevent the possibility of breakage." it is unknown as to whether the tools provided to defeat the hemostasis valve were used during the insertion into the introducer.Numed requested this information but did not receive a response.

Event Description

As per the report from the distributor / user facility - before stent was deployed in the patient a defect was noted/seen in one of the stent struts.The stent was extracted from the patient via the catheter.Procedure aborted - rescheduled.No impact to the patient.

• Brand Name: COVERED MOUNTED CP STENT
• Type of Device: 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: 11464744
• MDR Text Key: 242244837
• Report Number: 1318694-2021-00002
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 428
• Device Catalogue Number: CMCP033
• Device Lot Number: CMCP-2582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Date Manufacturer Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1