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

Model Number N/A

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2012

Event Type  malfunction  

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 "device unable to be retrieved, chest pain, shortness of breath, bleeding". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. 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. Unknown if the reported chest pain, shortness of breath, and bleeding is directly related to the filter and unable to identify a corresponding failure mode at this point in time. According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e. G. , the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.

Manufacturer Narrative

William cook europe initially reported event under mfr report # 3002808486-2016-00083. 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 # 1820334-2016-00277, follow up # 1. This was in reference to william cook europe mfr report # 3002808486-2016-00083. Cook is now submitting an initial report to correct this issue. (b)(4). Evaluation- the product was not returned to assist with the investigation. No information regarding the event was provided. No notes of relevance found in the device work order, nor on the filter lot number. No other complaints have been received relevant to this lot. Impossible to comment on the alleged injuries. Device manufactured/inspected according to specifications. There is no evidence to suggest the device was not manufactured to specifications. No evidence to suggest a device failure. We have notified appropriate personnel and will continue to monitor for similar events. If additional information is received, the report will be reopened for further investigation.

Event Description

It is alleged that patient received a cook gunther tulip filter on (b)(6) 2015 at (b)(6) medical center in (b)(6). It is alleged that patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

The event is currently under investigation.

Event Description

It is alleged that patient received a cook gunther tulip filter on (b)(6) 2015 at the (b)(6)medical center. It is alleged that patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4). Investigation/evaluation: during the course of the investigation, a review of the device history record of the product was conducted. There was not any information provided regarding the event. We have investigated the complaint based on the information received to date, and are closing the report until further information is received for investigation. Impossible to comment on alleged "punitive damages". If additional information is received, the report will be re-opened for further investigation. We have notified appropriate personnel and will continue to monitor for similar events.

Event Description

It is alleged that patient received a cook gunther tulip filter on (b)(6) 2015 at the (b)(6) medical center in (b)(6). It is alleged that patient was injured without further explanation. Patient is seeking punitive damages. 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 03/18/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2012 via the right internal jugular vein due to history of dvt, pe preparing for surgery. Plaintiff is alleging device unable to be retrieved, chest pain, shortness of breath, bleeding. Plaintiff alleges attempted retrieval on (b)(6).

• 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 Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5637582
• MDR Text Key: 151730121
• Report Number: 1820334-2016-00277
• 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: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• 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?: No
• Event Location: Other
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/01/2011
• 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: 05/06/2016 Patient Sequence Number: 1