MAUDE Adverse Event Report: COOK BIRDS NEST FILTER; IVC FILTER

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Sticking (1597)

Patient Problem No Code Available (3191)

Event Type  No Answer Provided  

Event Description

I would like to file a formal complaint with the fda.I have a cook medical ivc birds nest filter that has fractured and migrate.Parts of this device is sticking in my abdominal aorta, part is sticking in my renal vein, and the rest is spread throughout my body.I would also like to know if there has been a recall on this filter as the fda only allows removable filter to be implanted for no longer than 5 yrs."if so why was i never contacted," i am filing this complaint with the fda and do not simply want this sent to cook medical.I am in the process of gathering other same with the same problem as mine and they will be filing a complaint also in order to get a recall issued if one has not already been issued.Looking to hear back from the fda and not cook medical.Thanks for your help in this matter.(b)(6).

• Brand Name: BIRDS NEST FILTER
• Type of Device: IVC FILTER
• Manufacturer (Section D): COOK
• MDR Report Key: 6331475
• MDR Text Key: 67654789
• Report Number: MW5067888
• Device Sequence Number: 1
• Product Code: DTK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1