MAUDE Adverse Event Report: NUMED, INC COVERED C-P STENT; AORTIC STENT

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Medtronic received information that three years following valve implant, fluoroscopy confirmed that a non-medtronic (manufacturer numed inc.) single wire covered c-p stent fragment embolized to the right pulmonary artery.No intervention was done and the patient will be followed up in 6 months.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: COVERED C-P STENT
• Type of Device: AORTIC STENT
• Manufacturer (Section D): NUMED, INC
• MDR Report Key: 17527533
• MDR Text Key: 321050506
• Report Number: MW5134465
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2012

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1