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

Model Number N/A

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135); Anxiety (2328); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/20/2016

Event Type  Injury  

Manufacturer Narrative

Additional information: it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "vena cava perforation, tilt, embedded tip". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Unknown if the reported vena cava perforation, tilt, embedded tip is directly related to the filter and unable to identify a corresponding failure mode at this point in time. Filter perforation of the vena cava wall is a known risk reported in the published scientific literature. Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall. There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae. E. G. Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae. In contrast, perforation of adjacent organs is reported with clinical sequelae. Filter tilt is a known potential complication of vena cava filters. Among other causes, filter tilt may be associated with placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e. G. , a surgical procedure in the vicinity of a filter) and (or) procedures that involve devices passing through a filter, or a failed retrieval attempt. Excessive filter tilt may result in loss of filter efficiency. Filter tilt is a known risk in relation to filter implant reported in the published scientific literature. Filter tilt may happen during placement or during implanting period.

Manufacturer Narrative

(b)(4). The event is currently under investigation.

Event Description

It is alleged that "[pt] received a gunther tulip/gunther (1820334-2016-01442) tulip mreye (1820334-2016-01441) on (b)(6) 2006 at (b)(6) hospital in (b)(6). " it is alleged that the patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56.

Event Description

It is alleged that "[pt] received a gunther tulip (1820334-2016-01442)/ gunther tulip mreye (1820334-2016-01441) on (b)(6) 2006 at (b)(6). " it is alleged that the patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 12/29/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2006 via the right internal jugular vein due to bilateral lower extremity trauma with high risk of dvt. Plaintiff is alleging vena cava perforation, tilt, embedded tip with successful retrieval on (b)(6) 2016.

• 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: 6151827
• MDR Text Key: 132586597
• Report Number: 1820334-2016-01442
• 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: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/23/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/07/2016 Patient Sequence Number: 1