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U.S. Department of Health and Human Services

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

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COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
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). 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.
 
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.
 
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Brand NameUNKNOWN
Type of DeviceDTK 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 Key6098452
MDR Text Key114220717
Report Number1820334-2016-01321
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received11/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date10/24/2016
Event Location No Information
Date Manufacturer Received10/03/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 11/14/2016 Patient Sequence Number: 1
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