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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JUG
Device Problems Fracture (1260); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Chest Pain (1776); Internal Organ Perforation (1987); Ventricular Tachycardia (2132); Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2009
Event Type  Injury  
Manufacturer Narrative
(b)(4).The event is currently under investigation.
 
Event Description
It is alleged that patient received a gunther tulip filter on (b)(6) 2008 at (b)(6).Physician allegedly placed the filter.On (b)(6) 2010 at (b)(6).Physician allegedly placed the filter.It is alleged that the patient was injured without further explanation.Patient is seeking punitive damages.Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
Changed to: it is alleged that "the patient received a gunther tulip filter on (b)(6) 2008 at (b)(6)." "it is alleged that the patient was injured without further explanation.Patient is seeking punitive damages.Hospital and medical records have been requested but not yet provided.".
 
Event Description
It is alleged that "the patient received a gunther tulip filter on (b)(6) 2008 at (b)(6)." it is alleged that the patient was injured without further explanation.Patient is seeking punitive damages.Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4).Lot # provided.Evaluation- the product was not returned to assist with the investigation.No information regarding the event was provided.No notes of relevance found in the device work order, nor on the filter lot number.No other complaints have been received relevant to this lot.Impossible to comment on the alleged injuries.Device manufactured/inspected according to specifications.There is no evidence to suggest the device was not manufactured to specifications.No evidence to suggest a device failure.We have notified appropriate personnel and will continue to monitor for similar events.
 
Event Description
It is alleged that "the patient received a gunther tulip filter on (b)(6) 2008 at (b)(6)." it is alleged that the patient was injured without further explanation.Patient is seeking punitive damages.Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4).Corrected data based on new information received: adverse event to product malfunction, serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on (b)(6) 2016 as follows: plaintiff allegedly received an implant on (b)(6) 2008 due to dvt, gunshot wound requiring surgery contraindication to anticoagulation.Plaintiff alleges attempted retrieval on (b)(6) 2009.Plaintiff is alleging tilt, vena cava perforation, device unable to be retrieved, ventricular tachycardia, chest pains, shortness of breath.
 
Manufacturer Narrative
The investigation was reopened due to additional information provided.The following allegations have been investigated: fracture.The reported allegations have been further investigated based on the information provided to date.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.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 report will be submitted should additional relevant information become available.
 
Event Description
Dated (b)(6) 2017, final report for abdominal/pelvic ct reports, "the reconstructed images confirm the fracture of a posterior limb of the patient's ivc filter.The fractured limb has eroded through the anterior cortex of l2 and is embedded in the vertebral body extending to the inferior endplate.The is seen right of midline no acute hemorrhage is seen.There is not retroperitoneal hematoma.".
 
Manufacturer Narrative
Additional information investigation - 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, "tulip, tilt, vc perforation, unable to retrieve, ventricular tachycardia, pain, shortness of breath." vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, 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.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.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.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.Unknown if the reported tachycardia, pain, and shortness of breath are directly related to the filter and unable to identify a corresponding failure mode at this 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.
 
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Brand Name
GUNTHER TULIP JUGULAR 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 Key5723260
MDR Text Key47337505
Report Number1820334-2016-00491
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/16/2019
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 NumberIGTCFS-65-JUG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Other
Initial Date Manufacturer Received 06/01/2016
Initial Date FDA Received06/14/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
10/03/2017
05/01/2019
Supplement Dates FDA Received10/13/2016
11/16/2016
06/07/2017
10/07/2017
05/16/2019
Date Device Manufactured07/25/2008
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; Other;
Patient Age37 YR
Patient Weight86
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