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

Model Number 428

Device Problems Difficult or Delayed Positioning (1157); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

The root cause of the complaint cannot be positively determined since the device was implanted in the patient and not returned.Films of the procedure were sent to numed to review but did not include videos of when the sheath was actually retracted and the stent fully exposed before inflation.The film skipped over that part of it and just showed the stent once the inner balloon had already been inflated.The stent was able to be used and the patient was fine post procedure.

Event Description

As per the report from bis: "the stent went through the sheath fine.After unsheathing, it was noticed that the stent was mounted distally before inflation, it had migrated.The physician was about to use the stent, it was just difficult to use.The stent was being used for a small conduit tear.An inflation device with pressure gauge was used.The catheter shaft was not kinked.There was nothing unusual about the patient anatomy.The patient was fine post procedure.Saline and contrast were both used during prep.The physician did inflate the inner balloon before the outer balloon, and did not attempt to pull the stent back through the hemostasis valve at any time.".

• Brand Name: COVERED AND 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: 6347045
• MDR Text Key: 68279831
• Report Number: 1318694-2017-00006
• Device Sequence Number: 1
• Product Code: PNF
• UDI-Device Identifier: 04046964899553
• UDI-Public: 04046964899553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2017

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
• Device Operator: Physician
• Device Expiration Date: 10/31/2021
• Device Model Number: 428
• Device Catalogue Number: CMCP026
• Device Lot Number: CMCP-1429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2016
• 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
• Patient Age: 15 YR
• Patient Weight: 51