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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 Problems Material Erosion (1214); Fracture (1260); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Blood Loss (2597); No Information (3190)
Event Date 07/15/2013
Event Type  Injury  
Manufacturer Narrative

(b)(4). Catalog#: unknown but referred to as a cook celect filter. Name and address for importer site: (b)(4). Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. (b)(4). Investigation is still in progress.

 
Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2013". 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). 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 06/19/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2013 via the common femoral vein due to deep vein thrombosis. Plaintiff is alleging vena cava perforation, organ perforation, bleeding, device migration and unable to be retrieved. Plaintiff alleges severe pain, shortness of breath, elevated white blood cell count, difficulty swallowing and an aversion to certain foods. Plaintiff alleges attempted retrieval on (b)(6) 2013 and retrieval on (b)(6) 2016 however a portion of the strut was not able to removed.

 
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 'vena cava and organ perforation, bleeding, migration, fracture, unable to be retrieved, pain, dyspnea'. 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 fracture is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position. Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e. G. Renal vein), 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. It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible. Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature. It is known from the published scientific literature that a filter fragment embolized into the heart or lung may be safely retrieved. 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 pain and dyspnea 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.

 
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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 Key6685292
MDR Text Key79026003
Report Number3002808486-2017-01367
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK073374
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 05/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/04/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/15/2014
Device Catalogue NumberIGTCFS-65-FEM-CELECT-PERM
Device LOT NumberE3008619
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/14/2017
Device Age8 mo
Event Location No Information
Date Manufacturer Received05/01/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/01/2012
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: 07/04/2017 Patient Sequence Number: 1
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