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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-UNI-CELECT
Device Problems Difficult to Remove (1528); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  malfunction  
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, k073374 or k090140.Mfr date: unknown as lot# is unknown.(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) 2011." 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).According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e.G., the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu.It has not been possible to fully investigate or evaluate this event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2011." 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).The event is currently under investigation.A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 12/13/2016 as follows: the plaintiff allegedly received device implant via right femoral vein on (b)(6) 2011 due to history of pe prior to abdominal surgery.The plaintiff alleges device is unable to be retrieved and second filter had to be placed after implant of device.
 
Manufacturer Narrative
Manufacturer reference #: (b)(4).Exemption number e2016032.(b)(4).Corrected data based on new information received: adverse event to product problem, serious injury to malfunction.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 "device unable to be retrieved and 2nd filter had to be placed after implant of device".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.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.
 
Event Description
Dated (b)(6) 2012, operative notes (inferior vena cava venograpy) reports, "both chronic and acute-appearing thrombus in the inferior vena cava, both about and below the inferior vena cava filter.This mixture of chronic and acute thrombus extended down into the right external iliac and right common femoral veins." dated (b)(6) 2012, ir ivc filter placement reports, "a suprarenal non-cook retrievable filter was deployed.".
 
Manufacturer Narrative
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: 2nd filter had to be placed after implant of device.Unknown if the reported issue "2nd filter had to be placed after implant of device" 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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: (b)(4).
 
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Brand Name
COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
MDR Report Key6208824
MDR Text Key63406809
Report Number3002808486-2016-01566
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT
Was Device Available for Evaluation? No
Distributor Facility Aware Date12/14/2016
Date Manufacturer Received05/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Weight86
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