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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); Malposition of Device (2616); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Dyspnea (1816); Decreased Respiratory Rate (2485); Device Embedded In Tissue or Plaque (3165); No Information (3190)
Event Date 11/02/2010
Event Type  Injury  
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 06/12/2017 as follows: the plaintiff allegedly received the filter implant via right internal jugular vein on (b)(6) 2009 due to bilateral massive pe. The filter was successfully removed percutaneously on (b)(6) 2010; however, per the medical record provided by the plaintiff, ¿(t)here is a single wire leg of that filter that was embedded in the wall and it broke off in the process of extraction. ¿ the plaintiff alleges tilt, fracture, migration, and compromised respiration.
 
Manufacturer Narrative
Exemption number e2016032. William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer). Manufacturer ref# (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; fracture during retrieval; migration; compromised respiration'. Cook will reopen its investigation if further information is received. Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement. Filter fracture is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position. Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e. G. Renal vein), 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. It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible. Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature. It is known from the published scientific literature that a filter fragment embolized into the heart or lung may be safely retrieved. 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 compromised respiration is 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.
 
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 09/01/2017 as follows: patient received an implant on (b)(6) 2009 via the right internal jugular vein due to bilateral massive pulmonary emboli and right lower extremity deep vein thrombosis. Patient is alleging migration, tilt, compromised respiration. The filter was retrieved on (b)(6) 2010. Patient experiences fracture of the filter device where one filter arm embedded in the caval wall that was not removed.
 
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). Corrected data based on new information received: [pt] provided product lot # e2632991 that correlates to the newly implanted ((b)(6) 2010) celect filter (no alleged problems) and does not correlate to the fractured celect filter (partially retrieved (b)(6) 2010). 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 'celect, tilt; fracture during retrieval; migration; compromised respiration'. 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. Filter fracture is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position. Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e. G. Renal vein), 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. It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible. Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature. It is known from the published scientific literature that a filter fragment embolized into the heart or lung may be safely retrieved. 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 compromised respiration 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 celect filter expiration date: unknown as lot# is unknown since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140 mfr date: unknown as lot# is unknown. (b)(4). Investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009". 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 referred to as a cook celect filter. Expiration date: unknown as lot # is unknown. Since catalog # is unknown the 510(k) could be either k061815, k073374 or k090140. 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 if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009. " patient outcome: it is alleged that [pt] was injured without further explanation. 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
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key6192239
MDR Text Key113546967
Report Number3002808486-2016-01519
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
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
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 Date12/09/2016
Device Age2 MO
Event Location No Information
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/01/2010
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: 12/21/2016 Patient Sequence Number: 1
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