MAUDE Adverse Event Report: COOK INC. CELECT IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

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

Patient Problem Reaction (2414)

Event Date 09/17/2020

Event Type  Injury  

Event Description

Celect ivc filter found to be multiple fractured and embolized.One leg in right kidney parenchyma, one arm in right renal vein, one arm retained locally, most of 1 leg extravascular and deeply embedded in vertebral body with bony sclerotic and lytic reaction, and one arm in a rml pulmonary artery.Fda safety report id # (b)(4).

• Brand Name: CELECT IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC.; bloomington IN
• MDR Report Key: 10566177
• MDR Text Key: 208368296
• Report Number: MW5096772
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• 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): Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 136