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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 Fracture (1260); Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Erosion (1750); Internal Organ Perforation (1987); Perforation of Vessels (2135); Injury (2348); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Manufacturer ref# (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 perforation, organ perforation, device is unable to be retrieved, other: erosion. Updated sfc. ". 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. Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature. Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic. 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). Lot#: unknown as information was not provided. Catalog#: unknown but referred to as a cook celect filter. Expiration date: unknown as lot# is unknown. Since catalog# is unknown the 510(k) could be either k061815 or k073374. Device mfr date: unknown as lot# is unknown. 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) 2008 at (b)(6) hospital in (b)(6). " 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). 510(k) k073374. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 07/15/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2008 via the right common femoral vein due to dvt. Plaintiff provided a ct report describing the filter with 'a tine projecting into the anterior aspect of the l3 vertebral body' and that the ivc is occluded. No retrieval attempts have been noted. Plaintiff is alleging vena cava perforation, organ perforation, device is unable to be retrieved, other: erosion.
 
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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
dk-4632 bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
dk-4632 bjaeverskov, IN 4632
DA   4632
8004574500
MDR Report Key5722319
MDR Text Key248077900
Report Number3002808486-2016-00535
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,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2016
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 Date06/08/2016
Event Location No Information
Date Manufacturer Received05/01/2019
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: 06/14/2016 Patient Sequence Number: 1
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