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

Model Number N/A

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

Patient Problems Pulmonary Embolism (1498); Death (1802); Blood Loss (2597)

Event Date 10/02/2014

Event Type  Death  

Manufacturer Narrative

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

Event Description

It is alleged that the patient received a cook gunther tulip on (b)(6) 2005 at (b)(6)." it is alleged that patient was injured (death) without further explanation.The patient's state is seeking punitive damages.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Please see updated corrected information.Patient code: death is listed as a potential adverse event in the ifu.Device code: no information regarding the event has been provided.It cannot be determined what may or may not have occurred based on the limited information "the patient is deceased" or if it in any way relates to the filter.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 receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

It is alleged that the ¿patient received a cook gunther tulip on (b)(6) 2005 at (b)(6) hospital in (b)(6)." it is alleged that patient was injured (death) without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4).The patient involved was reported to be deceased without further details, therefore this report is being submitted as ¿death¿ related as a cautionary measure.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 10/21/2016 as follows: plaintiff received an implant on (b)(6) 2005 via the jugular vein due to pe.Plaintiff is alleging death, bleeding, pe despite filter in place, acute respiratory failure, bilateral lower extremity swelling.Cook inc.Is not assuming responsibility for patient death, unclear the reason for death.

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 "pulmonary embolism, bleeding, acute respiratory failure, bilateral lower extremity swelling, and death." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.It is unknown if the reported death, bleeding, acute respiratory failure, or bilateral lower extremity swelling are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Pe is a known risk in relation to filter implant reported in the published scientific literature.Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins.With all filters, there is some risk of further pulmonary embolism.There is no evidence to suggest that this device was not manufactured according to specifications.

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

Pt allegedly received an implant on (b)(6) 2005 via the right internal jugular vein due to pulmonary embolism (pe).Pt has alleged bleeding, pe despite filter in place, acute respiratory failure, bilateral lower extremity swelling, and death.Further alleged, deep vein thrombosis.Pt has been reported as deceased, date of death (b)(6) 2014.

Manufacturer Narrative

Additional information: investigation.The additional information received doesn't change the previously completed investigation.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

No additional information provided at this time.

• Brand Name: UNKNOWN
• 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: 6098452
• MDR Text Key: 59723382
• Report Number: 1820334-2016-01321
• 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,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/24/2016
• Date Manufacturer Received: 10/03/2018
• 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): Death
• Patient Age: 52 YR