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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 Migration or Expulsion of Device (1395); Insufficient Information (3190)
Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Blood Loss (2597); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(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 ¿ivc filter - migration, vena cava perforation, organ perforation, bleeding, pain". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement. 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 and pain are directly related to the filter and unable to identify a corresponding failure mode at this point in time. Filter type and lot# are unknown. 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 reference # (b)(4). Exemption number e2016032. (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 31/jan/2018 as follows: patient received an implant on (b)(6) 2013 due to pulmonary embolism. Patient alleges that she had a previous filter implanted but it was removed. Patient did not provide a date or reason for the previous filter being removed. Patient is alleging migration, vena cava perforation, organ perforation, bleeding and pain due to the device.
 
Manufacturer Narrative
(b)(4). Lot#: unknown as information was not provided. Catalog#: unknown but referred to as an ivc filter. Expiration date: unknown as lot# is unknown. Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: it is alleged that "[pt] was implanted with an ivc filter and suffers ongoing injuries. " patient outcome: alleged that [pt] "have suffered permanent and continuous injuries, pain and suffering, disability and impairment. [pt] have suffered emotional trauma, harm and injuries that will continue into the future. [pt] have lost their ability to live a normal life, and will continue to be so diminished into the future. Furthermore, [pt] have lost earnings and will continue to lose earnings into the future and have medical bills both past and future related to care because of the ivc filters¿ defects. " hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Catalog #: unknown but referred to as an ivc filter. Expiration date: unknown as lot # is unknown. (b)(4). Since catalog # is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. Mfr date unknown as lot# is unknown. It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation after further information is received and will supplement in accordance with 21 c. F. R. 803. 56 when appropriate.
 
Event Description
Description of event according to initial reporter: it is alleged that "[pt] was implanted with an ivc filter and suffers ongoing injuries. " patient outcome: alleged that [pt] "have suffered permanent and continuous injuries, pain and suffering, disability and impairment. [pt] have suffered emotional trauma, harm and injuries that will continue into the future. [pt] have lost their ability to live a normal life, and will continue to be so diminished into the future. Furthermore, [pt] have lost earnings and will continue to lose earnings into the future and have medical bills both past and future related to care because of the ivc filters¿ defects. " hospital and medical records have been requested but not yet provided.
 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632, IN 47404
8004574500
MDR Report Key6401713
MDR Text Key254624658
Report Number3002808486-2017-00803
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
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2017
Is this an Adverse Event Report? Yes
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?
Distributor Facility Aware Date02/28/2017
Event Location No Information
Date Manufacturer Received02/21/2018
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: 03/14/2017 Patient Sequence Number: 1
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