MAUDE Adverse Event Report: COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-JUG

Device Problems Complete Blockage (1094); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Thrombus (2101); Perforation of Vessels (2135); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Evaluation: it has not been possible to further 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. Document review was completed and included the following: review of complaint history, device history record, mi, qc, 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. 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.

Manufacturer Narrative

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

Event Description

This additional information was received on 08/03/2016 as follows: the plaintiff allegedly received the device implant on (b)(6) 2007 via the jugular vein due to extensive dvt. The plaintiff alleges device is unable to be retrieved, device is clogged, bleeding, blood clots, severe pain, collapsed veins in right lower leg and severe pain, infections due to clogged veins.

Manufacturer Narrative

William cook (b)(4) initially reported event under mfr report # 3002808486-2016-00373. New information was received identifying that the product was a cook inc. Manufactured device. An updated emdr report was submitted under cook inc. Mfr report # 1820334-2016-00846, follow up # 1. This was in reference to william cook (b)(4) mfr report # 3002808486-2016-00373. Cook is now submitting an initial report to correct this issue. Blank fields on this form indicate the information is unknown or unavailable. (b)(4). Evaluation- the device was not returned to assist with the investigation. No information regarding the event was provided. We have investigated based on the information received to date, and are closing the report until further information is received for investigation. Impossible to comment on the alleged injuries. There is no evidence to suggest the device was not manufactured to specifications. If additional information is received, the report will be re-opened for further investigation.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received several cook celect filters and gunther tulip filters in (b)(6) 2007 at (b)(6) medical center in (b)(6). " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Initial mdr was submitted by william cook europe under reference # 3002808486-2016-00373. Additional information provided on (b)(6) 2016 determined this device was manufactured by cinc. Patient code: no known consequences reported. Device code: no known device problem reported. Evaluation- the device was not returned to assist with the investigation. No information regarding the event was provided. We have investigated based on the information received to date, and are closing the report until further information is received for investigation. Impossible to comment on the alleged injuries. There is no evidence to suggest the device was not manufactured to specifications. If additional information is received, the report will be re-opened for further investigation.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received several cook celect filters and gunther tulip filters in (b)(6) 2007 at kaiser permanente medical center in (b)(6). " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.

• Brand Name: GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5920892
• MDR Text Key: 109811847
• Report Number: 1820334-2016-00846
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072240
• 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,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IGTCFS-65-JUG
• 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: 08/03/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/01/2016 Patient Sequence Number: 1