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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JUG-CELECT-PERM
Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Malposition of Device (2616); Insufficient Information (3190)
Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Internal Organ Perforation (1987); Injury (2348)
Event Date 12/11/2015
Event Type  Injury  
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 05/20/2016 as follows: the plaintiff allegedly received the filter implant via right internal jugular vein on (b)(6) 2013 due to dvt. The device allegedly was successfully retrieved on (b)(6) 2015; however, a fragment of the filter allegedly remains in the plaintiff¿s right lung. The plaintiff alleges organ perforation, fracture, migration, tilt, atrial fibrillation, pain, chest pain, shortness of breath, and anxiety.
 
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 ¿fracture during explant, organ perforation, migration, tilt, atrial fibrillation, chest pain, and shortness of breath". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. 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 filter fragment embolized into the heart or lung may be safely retrieved. 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 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 atrial fibrillation, chest pain, or shortness of breath is directly related to the filter and unable to identify a corresponding failure mode at this point in 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). 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, k073374, k090140, k112119, k121057 or k121629. 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) 2013 at (b)(6) medical center. " 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 JUGULAR 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 Key5580317
MDR Text Key113546349
Report Number3002808486-2016-00223
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,Followup
Report Date 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/14/2015
Device Catalogue NumberIGTCFS-65-JUG-CELECT-PERM
Device Lot NumberE3121919
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/14/2016
Device Age28 MO
Event Location No Information
Date Manufacturer Received04/08/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/01/2013
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: 04/15/2016 Patient Sequence Number: 1
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