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

Model Number N/A

Device Problems Difficult to Remove (1528); Insufficient Information (3190)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Bruise/Contusion (1754); Blood Loss (2597); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The event is currently under investigation. A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 21/dec/2017 as follows: patient received an implant on (b)(6) 2007 via the right internal jugular vein due to pulmonary embolism and deep vein thrombosis. Patient is alleging filter legs embedded, bleeding, bruising easily, blood thinners and monthly inr check due to the device. Patient alleges that the device is unable to be retrieved. Retrieval was attempted on (b)(6) 2008 and (b)(6) 2008.

Manufacturer Narrative

A filter that is embedded in the wall of the ivc may be difficult to retrieve. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs. Complex. Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques. 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.

Event Description

This additional information received on 21/dec/2017 as follows: patient received an implant on (b)(6) 2007 via the right internal jugular vein due to pulmonary embolism and deep vein thrombosis. Patient is alleging filter legs embedded, bleeding, bruising easily, blood thinners and monthly inr check due to the device. Patient alleges that the device is unable to be retrieved. Retrieval was attempted on (b)(6) 2008 and (b)(6) 2008.

Manufacturer Narrative

(b)(4). Corrected data based on new information received: adverse event to product problem. Serious injury to malfunction. Blank fields on this form indicate the information is unknown or unavailable, or unchanged. The event is currently under investigation. A supplemental report will be provided upon conclusion.

Manufacturer Narrative

The event is currently under investigation. A supplemental report will be submitted upon completion.

Event Description

It is alleged that the plaintiff received a gunther filter on (b)(6) 2007. It is alleged that the plaintiff was injured without further explanation. Hospital and medical records have been requested but not yet provided.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7123140
• MDR Text Key: 258205662
• Report Number: 1820334-2017-04441
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/15/2017 Patient Sequence Number: 1