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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-CELECT
Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Edema (1820); Pain (1994); Swelling (2091); Thrombus (2101); Perforation of Vessels (2135); No Information (3190)
Event Type  malfunction  
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 'migration, tilt, vc perforation, device is unable to be retrieved, deep vein thrombosis, embedded '. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement. 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 peripheral vein thrombosis is directly related to the filter and unable to identify a corresponding failure mode 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). Corrected data: adverse event to product problem, life-threatening to blank, serious injury to malfunction. (b)(4). Name and address for importer site: (b)(4). 510 (k) k090140. The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
This additional information received on 15dec2017 as follows: patient received an implant on (b)(6) 2014 via the left femoral vein due to increased risk for pulmonary embolism. Pt alleges migration, tilt, vena cava perforation, device is unable to be retrieved, deep vein thrombosis and embedded. Filter retrieval was attempted on (b)(6) 2014. The retrieval attempt was unsuccessful.
 
Manufacturer Narrative
(b)(4). (b)(4). Catalog# is unknown but referred to as cook celect filter. (b)(4). Since catalog# is unknown 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. 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 of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014". Patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
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Brand NameCOOK CELECT NAVALIGN 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 Key7056752
MDR Text Key250431075
Report Number3002808486-2017-02265
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
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 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/22/2016
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT
Device Lot NumberE3158146
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date11/02/2017
Event Location No Information
Date Manufacturer Received08/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/01/2013
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: 11/23/2017 Patient Sequence Number: 1
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