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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-FEM-CELECT-PERM
Device Problem Occlusion Within Device (1423)
Patient Problems Pulmonary Embolism (1498); Death (1802); Pain (1994); Claudication (2550)
Event Date 09/10/2014
Event Type  Death  
Manufacturer Narrative
(b)(4). Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140. (b)(4). Summary of investigational findings: patient's medical records are unknown at this time and no imaging is provided. Therefore, no conclusion can be drawn based on the incomplete information provided regarding the leg pain and death of the patient more than 4 years after filter placement, nor on autopsy revealing "massive bilateral acute pulmonary embolism; deep venous thrombosis and complete occlusion of the left iliac vein; and a recent pre-mortem thrombus within the ivc filter. " based on the limited information available in this complaint, it remains unknown if the filter performance was related to this occurrence and therefore the exact root cause is unknown. However, 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. 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. Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to initial reporter: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009 prior to a spinal procedure. " "on or about (b)(6) 2014, [pt] complaining of leg pain, while walking. There, he was admitted and found to have symptoms consistent with neurogenic claudication likely secondary to an exacerbation of his lumbar spinal stenosis. Pain management and physical therapy was started. After a physical therapy session, the [pt] became unexpectedly lightheaded while climbing the stairs. He then became unresponsive and ultimately died on (b)(6) 2014. " "the final pathologic findings of an autopsy performed at the (b)(6) revealed massive bilateral acute pulmonary embolism; deep venous thrombosis and complete occlusion of the left iliac vein; and a recent pre-mortem thrombus within the ivc filter. " patient outcome: patient deceased on (b)(6) 2014.
 
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 was received on 04/28/2017 as follows: the patient allegedly received the filter implant on (b)(6) 2009 for dvt. The patient died on (b)(6) 2014. The patient¿s estate alleges death due to caval thrombus, dvt of left iliac vein, and massive bilateral pe.
 
Manufacturer Narrative
(b)(4). Corrected data based on new information received: adverse event and product problem to adverse event. Complaint was reopened since lot# was provided. However, since this is the only additional information received the below investigation information is still valid and remains unchanged: patient's medical records are unknown at this time and no imaging is provided. Therefore, it is impossible to comment on the reported leg pain and death of the patient more than 4 years after filter placement. Also, it is impossible to comment on autopsy revealing "massive bilateral acute pulmonary embolism; deep venous thrombosis and complete occlusion of the left iliac vein; and a recent pre-mortem thrombus within the ivc filter. " based on the limited information available in this complaint, it remains unknown if the filter performance was related to this occurrence and therefore the exact root cause is unknown. However, 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. 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.
 
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Brand NameCOOK CELECT FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632, IN 47404
8004574500
MDR Report Key6016287
MDR Text Key56909535
Report Number3002808486-2016-01199
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIGTCFS-65-FEM-CELECT-PERM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date09/15/2016
Device Age67 MO
Event Location No Information
Date Manufacturer Received08/30/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/18/2009
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: 10/11/2016 Patient Sequence Number: 1
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