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

Model Number 427

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

The covered cp stent was placed in the patient in (b)(6) 2007; 11 years later the patient developed recoarctation of the aorta and underwent placement of a second cp stent.It was during this placement that it was noticed that the original covered cp stent had fractured.A review of the pictures and film that was sent to numed confirmed the fractures of the device.All pieces are accounted for on the cp stent.None of the pieces or wires had detached completely from the stent.Stent fracture is a known risk with this type of device.There were (15) stents manufactured in this lot.There have been no other fractures reported for this lot of covered cp stents.(b)(4).

Event Description

Numed received an email stating that a patient in (b)(6) came in for a second cp stent for recoarctation of the aorta.During the placement of the second cp stent, it was noticed that the original covered cp stent had fractured.The original covered cp stent was placed in this patient in (b)(6) 2007.

• Brand Name: COVERED 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: 8090910
• MDR Text Key: 128265659
• Report Number: 1318694-2018-00016
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2018

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: No Information
• Device Expiration Date: 08/31/2012
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z39
• Device Lot Number: CCP-0221
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1