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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); Appropriate Term/Code Not Available (3191)
Patient Problems Hematoma (1884); Perforation (2001); Perforation of Vessels (2135); Injury (2348); Blood Loss (2597)
Event Date 08/21/2009
Event Type  Injury  
Manufacturer Narrative
Exemption number e2016032. (b)(4). 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 ¿vc perforation, bleeding, hematoma, pain, infection, walking difficulty, anxiety". 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. 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. Unknown if the reported bleeding, hematoma, pain are directly related to the filter. Unknown if the reported infection, difficulty walking, anxiety are directly related to the filter and unable to identify a corresponding failure mode at this point in time. Rpn and lot# are unknown, but the filter celect 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
(b)(4). Exemption number e2016032. 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 19apr2018 as follows: pt allegedly received an implant on (b)(6) 2009 via the right internal jugular vein due to deep vein thrombosis (dvt). Pt is alleging vena cava perforation, bleeding, hematoma at ivcf placement site and pain post implant. Pt. Further alleges infection, inability to walk without a walker and anxiety.
 
Manufacturer Narrative
(b)(4). Age/date of birth) unknown as information was not provided. Weight) unknown as information was not provided. Brand name) unknown as information was not provided. Lot#: unknown as information was not provided. Catalog#: unknown but refered to as a cook celect filter. Expiration date: unknown as lot# is unknown. Since catalog# is unknown the 510(k) could be either k061815, k07337 or k090140. Device manufacture date) unknown as lot# is unknown. Investigation is still in progress.
 
Event Description
Description of event according complainant: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009 in (b)(6). In or around (b)(6) 2009, [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] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Catalog#: unknown but refered to as a cook celect filter. Since catalog# is unknown the 510(k) could be either k061815, k07337 or k090140. (b)(4). 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 approx. 2 days after placement of a celect 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. 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 of event according complainant: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009. In or around (b)(6) 2009, [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] was injured without further explanation. Hospital and medical records have been requested but not et provided.
 
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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
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key5741018
MDR Text Key263224890
Report Number3002808486-2016-00571
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
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 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2016
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 Received05/17/2018
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: 06/22/2016 Patient Sequence Number: 1
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