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); Insufficient Information (3190)

Patient Problems Pain (1994); Disability (2371); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/09/2010

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.

Event Description

It is alleged that the patient "received a gunther tulip filter on (b)(6) 2009 at (b)(6) clinic 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

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

Event Description

It is alleged that the patient "received a gunther tulip filter on (b)(6) 2009 at (b)(6)." it is alleged that patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

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 in the situations described in the ifu.It has not been possible to fully investigate or evaluate this 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.

Manufacturer Narrative

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

Event Description

This additional information was received on 01/06/2017 as follows: the patient allegedly received the device implant via the right internal jugular vein on (b)(6) 2009 as pe prophylaxis following pelvic fracture.An unsuccessful attempt to remove the device was allegedly made on (b)(6) 2010.The patient is alleging device is unable to be retrieved.

Manufacturer Narrative

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 "the patient is alleging device is unable to be retrieved¿.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.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 in the situations described in the ifu.

Event Description

Patient alleges pain and disability.

• 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: 6157731
• MDR Text Key: 61881270
• Report Number: 1820334-2016-01549
• 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: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IGTCFS-65-JUG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/07/2016
• Device Age: 6 MO
• Date Manufacturer Received: 06/25/2017
• Date Device Manufactured: 07/27/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Weight: 89