• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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); Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Dizziness (2194)
Event Type  Injury  
Manufacturer Narrative

Manufacturer ref# (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 k090140, k061815 or k073374. (b)(4). Investigation is still in progress.

 
Event Description

Description according to short form complaint filed. It is alleged that "on (b)(6) 2011, [pt] had the cook celect vena cava filter inserted. This cook celect vena cava filter later broke and caused [pt] significant pain. On (b)(6) 2015 [pt] was hospitalized due to falling caused by a leg of the vena cava filter chronically eroding the anterosuperior endplate of the l4 vertebrae. A neurosurgical evaluation found the leg of the inferior vena cava filter protruding through the inferior vena cava and into the vertebral body and causing the autonomic/vagal symptoms of dizziness and nausea. Further vascular evaluation caused concern for potential hemorrhage and that removal is a surgical risk that is not safe to validate. " patient outcome: it is alleged "[pt] caused to suffer severe pain and serious bodily injury in the nature of severe pain which required hospital stays, treatment and numerous tests and doctors visits. In addition, [pt] has been caused to incur great expense for medical treatment of her injury, to endure great pain of the body and mind due to the injuries, and related medical treatment. ".

 
Manufacturer Narrative

(b)(4). Catalog#: unknown but referred to as a cook celect filter. Since catalog# is unknown the 510(k) could be either k090140, k061815 or k073374. (b)(4). Summary of investigational findings: investigation is solely based on description of event. No product was returned and no imaging was provided. According to the description of event, the celect filter alleged 'broke' (assumed to be fractured) as well as perforated the ivc and into the vertebral body. However, based on the limited information provided, it would be inappropriate to speculate on what may or may not have led to the reported filter fracture and perforation of the ivc. 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. 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. 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. Cook medical will continue to monitor for similar events.

 
Event Description

Description according to short form complaint filed. It is alleged that "on (b)(6) 2011, [pt] had the cook celect vena cava filter inserted. This cook celect vena cava filter later broke and caused [pt] significant pain. On (b)(6) 2015 [pt] was hospitalized due to falling caused by a leg of the vena cava filter chronically eroding the anterosuperior endplate of the l4 vertebrae. A neurosurgical evaluation found the leg of the inferior vena cava filter protruding through the inferior vena cava and into the vertebral body and causing the autonomic/vagal symptoms of dizziness and nausea. Further vascular evaluation caused concern for potential hemorrhage and that removal is a surgical risk that is not safe to validate. " patient outcome: it is alleged "[pt] caused to suffer severe pain and serious bodily injury in the nature of severe pain which required hospital stays, treatment and numerous tests and doctors visits. In addition, [pt] has been caused to incur great expense for medical treatment of her injury, to endure great pain of the body and mind due to the injuries, and related medical treatment. ".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 IN 47404
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632, IN 47404
8123392235
MDR Report Key6212092
MDR Text Key63475027
Report Number3002808486-2016-01565
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
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
Report Date 09/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/27/2012
Device Catalogue NumberIGTCFS-65-JUG-CELECT-PERM
Device LOT NumberE2684404
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/27/2010
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: 12/29/2016 Patient Sequence Number: 1
-
-