• 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 NAVALIGN FEMORAL 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 NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-CELECT
Device Problems Structural Problem (2506); Appropriate Term/Code Not Available (3191)
Patient Problems Chest Pain (1776); Dyspnea (1816); Perforation of Vessels (2135); Discomfort (2330); Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
It has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number are unknown, however, the alleged celect is manufactured and inspected according to specifications.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.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.
 
Event Description
It is alleged that the patient received a celect filter on (b)(6) 2012, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
 
Manufacturer Narrative
Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: vena cava (vc) perforation, chest pain, dyspnea, discomfort.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Unknown if the reported chest pain, dyspnea, and discomfort are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) in lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to specifications.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 will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
Patient allegedly received an implant due to pulmonary embolism (pe).Patient is alleging vena cava perforation.Patient notes and further alleges experiencing "i feel discomfort sometimes which feels like something out of place", shortness of breath and chest pain.Per a computed tomography (ct) abdomen without contrast: "inferior vena cava filter in expected position.Tips of filter legs protrude up to 6 mm beyond the caval wall, without evidence of extension into any adjacent organ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
MDR Report Key11444561
MDR Text Key244176296
Report Number3002808486-2021-00932
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 08/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/04/2015
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT
Device Lot NumberE2854515
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/22/2021
Initial Date FDA Received03/09/2021
Supplement Dates Manufacturer Received07/14/2021
Supplement Dates FDA Received08/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Weight125
-
-