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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-UNI-CELECT
Device Problems Material Erosion (1214); Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Perforation (2001); Perforation of Vessels (2135); No Information (3190)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Catalog#: unknown but referred to as a cook celect filter. Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140. 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

Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2010¿. Patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.

 
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 02/4/2017 as follows: patient allegedly received device implant via right groin on (b)(6) 2010 due to pulmonary embolism, dvt, and gi bleeding. Patient is alleging vena cava perforation and that device is unable to be retrieved.

 
Manufacturer Narrative

(b)(4). 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.

 
Manufacturer Narrative

Exemption number e2016032. (b)(4). Manufacturer reference #(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 "patient is alleging vena cava perforation and that 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 perforation of the vena cava wall is a known risk reported in the published scientific literature. Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall. 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. 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

Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

This additional information received on 09/08/2017 as follows: patient received an implant on (b)(6) 2010 via the right common femoral vein due to pulmonary embolism and deep vein thrombosis. Patient experiences filter eroded, vena cava perforation and protruded hook from filter. Patient is alleging device tilt, embedment, perforation grade 1,2 and 3, and stabbing pain in stomach due to the device. Patient alleges device is unable to be retrieved. No documentation provided regarding an attempted retrieval.

 
Manufacturer Narrative

Manufacturer reference # (b)(4). 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, eroded filter, tilt, embedded, vc perforation level 1,2,3, unable to retrieve, pain in stomach'. 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. Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period. Unknown if the reported pain in stomach 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.

 
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Brand NameCOOK CELECT NAVALIGN JUGULAR & 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 Key6313663
MDR Text Key66859474
Report Number3002808486-2017-00401
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK090140
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 04/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/24/2017
Event Location No Information
Date Manufacturer Received03/31/2020
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: 02/09/2017 Patient Sequence Number: 1
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