MAUDE Adverse Event Report: COOK CELECT; IVC FILTER

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 12/20/2017

Event Type  Injury  

Event Description

Celect filter placed in 2014 found to be fractured and deeply embedded in vertebral body, no prior attempt at removal.Pt has severe chronic back pain, narcotic dependent, almost certainly as a result of this filter penetration.Removed filter with forceps (tip-embedded).Also penetrated anteriorly with leg in duodenum, pt has had gi bleeding possibly related to filter penetration.Fragment which is extravascular left behind.

• Brand Name: CELECT
• Type of Device: IVC FILTER
• Manufacturer (Section D): COOK; bloomington IN
• MDR Report Key: 7142109
• MDR Text Key: 95755994
• Report Number: MW5074178
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 59