MAUDE Adverse Event Report: COOK INC UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 12/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event is currently under investigation.

Event Description

The patient had an ivc filter placed approximately 2 1/2 to 3 years.During a venogram, it was noted that the hook was embedded.In an attempt to remove the filter, one of the struts broke and remained embedded in the tissue.The cardiologist decided to not continue with the procedure and will keep an eye on the patient.The patient is stable at this time.According to the initial reporter, the patient is stable and did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation results - a review of complaint history, as well as a review of manufacturing instructions, quality control processes, and a review of trends was conducted.No product was returned and no imaging provided.Based on the information solely it is impossible to comment on the hook embedment and the filter retrieval resulting in the one of the struts to break and remain embedded in the tissue.Filter retrieval is occasionally difficult.This is well known from published scientific literature where filter retrievals are referred to as simple versus complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Lot# unknown, however tulip filter is manufactured and inspected according to manufacturing specifications.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.There is no evidence to suggest that device was not manufactured to specifications.No conclusion could be drawn based on the information available.Cook inc.Will continue to monitor for similar events.

Event Description

The patient had an ivc filter placed approximately 2 1/2 to 3 years.During a venogram, it was noted that the hook was embedded.In an attempt to remove the filter, one of the struts broke and remained embedded in the tissue.The cardiologist decided to not continue with the procedure and will keep an eye on the patient.The patient is stable at this time.According to the initial reporter, the patient is stable and did not experience any adverse effects due to this occurrence.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5346569
• MDR Text Key: 35552546
• Report Number: 1820334-2016-00025
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/30/2015
• Event Location: Hospital
• Date Manufacturer Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening