MAUDE Adverse Event Report: COOK CELECT; IVC FILTER

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 12/20/2017

Event Type  Injury  

Event Description

Celect ivcf placed in (b)(6) 2010, failed retrieval attempt in 2010.Found to have 2 fractured arms of the filter.One immediately posterior to the ivc and one remote from the ivc in the retroperitoneum.The tip was embedded.The filter was removed successfully with forceps, but the fragments are extravascular and not accessible to a transvenous approach.Will follow with serial imaging.

• Brand Name: CELECT
• Type of Device: IVC FILTER
• Manufacturer (Section D): COOK; bloomington IN
• MDR Report Key: 7142234
• MDR Text Key: 95742582
• Report Number: MW5074193
• 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?: No
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 70