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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 Fracture (1260); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)
Patient Problems Pain (1994); Perforation (2001); Perforation of Vessels (2135); Injury (2348); Chest Tightness/Pressure (2463); Blood Loss (2597)
Event Date 03/27/2012
Event Type  malfunction  
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 11/14/2017 as follows: patient received an implant on (b)(6) 2011 via the left common femoral vein due to right lower extremity deep venous thrombosis, status post pulmonary embolism in the past with inability to be anticoagulated. Patient is alleging tilt; vena cava perforation, bleeding, pain, fatigue, pain in chest due to the device. Patient alleges that the device is unable to be retrieved. Retrieval was attempted on (b)(6) 2012.
 
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). 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 'tilt, vena cava perforation, bleeding, device unable to be retrieved, pain, fatigue, tight pain in chest'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. 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 bleeding, fatigue is directly related to the filter and unable to identify corresponding failure mode(s) 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.
 
Manufacturer Narrative
(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) 2011, [pt] had a cook gunther tulip ivc filter implanted (b)(6) pursuant to a doctor's order. On or around (b)(6) 2012, [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. " patient outcome: 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). Lot#: unknown as information was not provided. Catalog#: unknown but referred to as a cook günther tulip filter. Expiration 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, which patient allegedly suffered approx. 3 months after placement of a tulip filter, because the filter became "imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable. " 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). Fracture of filter legs is a known risk reported in the published scientific literature. Filter perforation of the vena cava wall is a known risk reported in the published scientific literature. 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) 2011, [pt] had a cook gunther tulip ivc filter implanted in the state of (b)(6), pursuant to a doctor's order. On or around (b)(6) 2012, [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. " patient outcome: 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 NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key5513186
MDR Text Key250900190
Report Number3002808486-2016-00120
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
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
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/21/2016 Patient Sequence Number: 1
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