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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 Insufficient Information (3190)
Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Hemoptysis (1887); Hemorrhage/Bleeding (1888); Pain (1994); Vomiting (2144)
Event Type  Injury  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Corrected data based on new information received: adverse event to product problem, serious injury to malfunction, corrected to (b)(6), 510(k) updated to k073374. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 09/01/2017 as follows: patient received an implant on (b)(6) 2007 via the common femoral vein due to pulmonary embolus, pulmonary hypertension. Patient is alleging bleeding, pain in right side, felt filter shift inside body, hemoptysis.
 
Manufacturer Narrative
Exemption number e2016032. (b)(4). 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 'celect, bleeding, pain in right side, chest pain, coughing up blood, difficult to remove'. 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 bleeding, pain in right side, chest pain, coughing up blood is directly related to the filter and unable to identify corresponding failure mode(s) at this time. 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.
 
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Manufacturer Narrative
Exemption number e2016032. (b)(4). 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 'celect, vc perforation, bleeding, pain in right side, chest pain, coughing up blood, difficult to remove'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Vena cava wall perforation is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e. G. , a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter. There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae. E. G. Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae. In contrast, perforation of adjacent organs is reported with clinical sequelae. 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 bleeding, coughing up blood is directly related to the filter and unable to identify corresponding failure mode(s) at this time. 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.
 
Manufacturer Narrative
(b)(4). Investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] on (b)(6) 2007, was implanted with a cook celect@vena cava filter. Shortly after the implant on or around (b)(6) 2007, [pt] experienced chest pain and coughing up blood". Patient outcome: it is alleged that "[pt] continued to suffer symptoms and physical limitations, and she requires ongoing medical care, as a result of the multiple surgeries needed to remove the cook filter".
 
Manufacturer Narrative
(b)(4). Lot#: unknown as information was not provided. Catalog#: unknown but referred to as a cook celect filter. Expiration date: unknown as lot# is unknown. (b)(4) summary of investigational findings: no conclusion can be drawn based on the limited information provided that "[pt] on or about (b)(6) 2007, [pt] was implanted with a cook celect@vena cava filter at (b)(6) in (b)(6). Shortly after the implant on or around (b)(6) 2007, [pt] experienced chest pain and coughing up blood" and "[pt] continued to suffer symptoms and physical limitations, and she requires ongoing medical care, as a result of the multiple surgeries needed to remove the cook filter" - nor is it possible to confirm any relation to the filter. Medical records are unknown. 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. From the published scientific literature filter tilt inside ivc and/or embedment of filter legs or filter hook in the ivc wall is a well-known risk. Several case reports published in articles, describe successful retrievals of such filters by advanced retrieval techniques. 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 according to initial reporter: it is alleged that "[pt] on (b)(6) 2007, was implanted with a cook celect@vena cava filter. Shortly after the implant on or around (b)(6) 2007, [pt] experienced chest pain and coughing up blood". Patient outcome: it is alleged that "[pt] continued to suffer symptoms and physical limitations, and she requires ongoing medical care, as a result of the multiple surgeries needed to remove the cook filter".
 
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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 Key5839362
MDR Text Key249321702
Report Number3002808486-2016-00814
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,Followup
Report Date 08/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2009
Device Catalogue NumberIGTCFS-65-FEM-CELECT-PERM
Device Lot NumberE2065789
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date08/01/2016
Event Location No Information
Date Manufacturer Received08/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/02/2016 Patient Sequence Number: 1
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