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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-TULIP
Device Problems Entrapment of Device (1212); Fracture (1260); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616); Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Perforation of Vessels (2135); Injury (2348); Blood Loss (2597); No Information (3190)
Event Date 12/23/2010
Event Type  Injury  
Manufacturer Narrative
(b)(4). Exemption number e2016032. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
This additional information received on 24apr2018 as follows: pt allegedly received an implant on (b)(6) 2010 via the right common femoral vein due to prior deep vein thrombosis. Pt is alleging vena cava perforation, device is unable to be retrieved, bleeding, organ perforation - mesentery and aorta, embedment, caval thrombosis, deep vein thrombosis and lifelong anticoagulation. Pt. Further alleges extreme pain, lack of sleep, erectile dysfunction, swollen veins from groin almost down to knee and in inner thigh and lower abdomen, anxiety, mental anguish and stress. It is reported that pt. Expired on (b)(6) 2017, without further details.
 
Manufacturer Narrative
Exemption number e2016032. (b)(4). Additional information: investigation: investigation is reopened due to additional information provided. 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, vc+ organ perf. , thrombosis, tilt, unable to retrieve (embd), pain, dvt, anxiety, bleeding, (death)'. Cook will reopen its investigation after further information concerning alleged patient sufferings is received and will supplement in accordance with 21 c. F. R. 803. 56 when appropriate. Unknown if the reported patient death is related to the filter. 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. A filter that is embedded in the wall of the ivc may be difficult to retrieve. 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. Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature. Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic. Unknown if the reported pain/discomfort is directly related to the filter. Unknown if the reported anxiety or bleeding is directly related to the filter and unable to identify corresponding failure mode(s) at this time. Unknown if the reported peripheral vein thrombosis is directly related to the filter and unable to identify a corresponding failure mode at this time. No other complaints on lot. Product 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.
 
Manufacturer Narrative
Manufacturer ref# (b)(4). Catalog#: unknown but referred to as a cook günther tulip filter. Investigation is still in progress.
 
Event Description
Description according to complainant: it is alleged that "on or about (b)(6) 2010, [pt] had a cook gunther tulip ivc filter implanted at an unnamed hospital in the state of (b)(6), pursuant to a doctor's order. On or around (b)(6) 2010 [pt] suffered significant physical personal injuries directly and proximately caused by the aforementioned ivc filter becoming imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable. Patient outcome: it is alleged that "[pt] suffered significant physical personal injuries directly and proximately caused by the aforementioned ivc filter becoming imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable. As a direct and proximate result of these injuries, [pt] has incurred and will incur medical expenses in the future, has endured and will endure pain and suffering and loss of enjoyment of life, and [pt] has otherwise been damaged in a personal and pecuniary nature. ".
 
Manufacturer Narrative
(b)(4). Catalog #: unknown but referred to as a cook günther tulip filter. Expiration date: unknown as lot # is unknown. Mfr date unknown as lot # is unknown. Summary of investigational findings: patients medical records are unknown and no imaging is provided. Therefore, it is not possible to comment on the significant physical personal injuries directly and proximately caused by the ivc filter, which patient allegedly suffered almost 4 months after placement of a tulip filter, because the filter became "imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable. " also, it is not possible to comment on the medical expenses, which patient allegedly has incurred and will incur in the future, the pain and suffering and loss of enjoyment of life, the patient has endured and will endure, as well as the patient otherwise being damaged in a personal and pecuniary nature. Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during filter placement or during filter implanting period. Under normal conditions, i. E. Ivc < 30 mm, the radial force of the filter will ensure proper attachment of the filter legs to ivc. However, filter migration is a known risk in relation to filter implant reported in the published scientific literature. Manipulation in the area of the filter implant or a blood clot captured inside the filter may cause migration or contribute to changes in the filter configuration and placement. Ifu, contraindications: megacava (diameter of the ivc > 30mm). Filter perforation of the vena cava wall is a known risk reported in the published scientific literature. Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall. 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. From the published scientific literature filter tilt inside ivc and/or embedment of filter legs or filter hook in the ivc wall is a well-known risk. Several case reports published in articles, describe successful retrievals of such filters by advanced retrieval techniques. Rpn and lot # are unknown, but 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 medical will continue to monitor for similar events.
 
Event Description
Description according to complainant: it is alleged that "on or about (b)(6) 2010, [pt] had a cook gunther tulip ivc filter implanted pursuant to a doctor's order. On or around (b)(6) 2010 [pt] suffered significant physical personal injuries directly and proximately caused by the aforementioned ivc filter becoming imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable. Patient outcome: it is alleged that "[pt] suffered significant physical personal injuries directly and proximately caused by the aforementioned ivc filter becoming imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable. As a direct and proximate result of these injuries, [pt] has incurred and will incur medical expenses in the future, has endured and will endure pain and suffering and loss of enjoyment of life, and [pt] has otherwise been damaged in a personal and pecuniary nature. ".
 
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Brand NameGUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
MDR Report Key5719726
MDR Text Key262035667
Report Number3002808486-2016-00513
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,Followup,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIGTCFS-65-1-FEM-TULIP
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/13/2016 Patient Sequence Number: 1
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