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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Pulmonary Embolism (1498); Transient Ischemic Attack (2109); Perforation of Vessels (2135); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.It has not been possible to investigate or evaluate this alleged 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
'it is alleged that "[pt] received a cook celect filter on (b)(6) 2014".It is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
155 ¿ 160lbs.Device code(s): appropriate term/code not available (3191) was selected for the alleged device tilt.Device code(s): appropriate term/code not available (3191) was selected for the alleged perforation.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: pulmonary embolism, vena cava perforation, deep vein thrombosis (dvt) and transient ischemic attack (tia).New pulmonary embolism (pe) as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: pulmonary embolism.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.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Unknown if the reported transient ischemic attack (tia) is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown; however, there is 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 medwatch report will be submitted if additional relevant information becomes available.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.
 
Event Description
Patient allegedly received an implant on (b)(6) 2014 via right common femoral vein due to pulmonary embolism.Patient is alleging pulmonary embolus, vena cava perforation, deep vein thrombosis (dvt) and transient ischemic attack (tia).Per a ct (computed tomography) scan of the abdomen and pelvis dated (b)(6) 2018, ¿¿stable position of ivc filter since (b)(6) 2017 with limbs extending beyond the lumen by up to 7 mm.¿.
 
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Brand Name
UNKNOWN
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
MDR Report Key8979165
MDR Text Key157041717
Report Number3002808486-2019-01406
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 11/13/2019
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 Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/20/2019
Initial Date FDA Received09/10/2019
Supplement Dates Manufacturer Received10/25/2019
Supplement Dates FDA Received11/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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