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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-FEM
Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)
Patient Problems Internal Organ Perforation (1987); Thrombus (2101); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative
Initial reporter occupation: non-healthcare professional.(b)(4).Investigation: the reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: fracture (fragment left in patient), vena cava (vc)/organ perforation, occlusive caval thrombus, tilt.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.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.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.A total of (b)(4) devices were manufactured in the reported 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 current controls.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.
 
Event Description
Patient allegedly received an implant on (b)(6) 2008 via right common femoral vein due to immobility and status post pelvic trauma.Patient is alleging fracture.Per a computerized tomography (ct) scan of the abdomen and pelvis dated (b)(6) 2017, ¿note is made of an ivc filter in place.The filter demonstrates approximately 11 degrees of right lateral tilt from axis of the ivc itself.The apex of the ivc filter touches the right anterior lateral aspect of the ivc wall.The tip of the ivc filter is located at the level of the left renal vein.The left anterior lateral strut (1:00 on the axial images) extends approximately 6 mm beyond the ivc wall and immediately abuts the second portion of the duodenum.The left posterior lateral strut (4:00 on axial images) extends approximately 17 mm beyond the ivc wall and is immediately juxtaposed to the anterior aspect of the vertebral body with evidence of osseous remodeling.The right posterior strut (7:00 on axial images) extends approximately 9 mm beyond the ivc wall and indents upon the anterior aspect of the right psoas muscle.The right anterior strut (10:00 on axial images) appears to remain within the ivc lumen.The ivc itself appears normal in caliber.¿ per a venogram bilateral lower extremities, thrombectomy dated (b)(6) 2019, ¿impression: occlusive caval thrombus from the iliocaval confluence through the level of the ivc filter.¿ per an interventional radiology (ir) ivc filter removal operative report dated (b)(6) 2019, ¿successful retrieval of an inferior vena cava filter, small retained fragment of ivc filter remaining, likely anomaly extraluminal in position.No embolized fragments were identified overlying the right or left chest.¿ /gjs 26feb2020.
 
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Brand Name
GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9772129
MDR Text Key192761003
Report Number1820334-2020-00510
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 02/28/2020
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 Date05/01/2011
Device Catalogue NumberIGTCFS-65-FEM
Device Lot Number2104461
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/24/2020
Initial Date FDA Received02/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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