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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-CELECT-PT
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Chest Pain (1776); Internal Organ Perforation (1987); Blood Loss (2597); No Information (3190); No Code Available (3191); Pericardial Effusion (3271)
Event Date 02/17/2015
Event Type  Injury  
Manufacturer Narrative
(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 ¿fracture, migration and unable to be retrieved, vena cava perf, bleeding, organ perf, paralyzed diaphragm". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Unknown if the reported bleeding, paralyzed diaphragm, shortness of breath and cpap, atrial fibrillation, periventricular contractions, premature atrial contractions, bradycardia syncope due to device is directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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. 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 filter fragment embolized into the heart or lung may be safely retrieved. 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. 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 platinum filter. Expiration date: unknown as lot # is unknown. Mfr date unknown as lot # is unknown. Investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook celect platinum filter on (b)(6) 2014. " 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). Lot#: unknown as information was not provided. Catalog#: unknown but referred to as a cook celect platinum filter. Expiration 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 platinum filter on (b)(6) 2014. " "on (b)(6) 2014, [pt] had a cook celect platinum ivc filter implanted in connection with gastric sleeve surgery. On (b)(6) 2015, [pt] reported to have the filter removed. Due to filter migration and embedding in the svc/ij junction, surgical removal was not feasible. Following discharge to her home [pt] began having (on (b)(6) 2015) significant chest pain and decreased blood pressure. Transthoracic echocardiogram revealed a large pericardial effusion and collapse of the right atrium and right ventricle. A pericardial drain was implanted. Emergent surgery was performed to remove the filter and fragments. " patient outcome: "following discharge to her home [pt] began having (on (b)(6) 2015) significant chest pain and decreased blood pressure. Transthoracic echocardiogram revealed a large pericardial effusion and collapse of the right atrium and right ventricle. A pericardial drain was implanted. Emergent surgery was performed to remove the filter and fragments. " hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
Manufacturer ref# (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 platinum filter on (b)(6) 2014. " "on (b)(6) 2014, [pt] had a cook celect platinum ivc filter implanted in connection with gastric sleeve surgery. On (b)(6) 2015, [pt] reported to have the filter removed. Due to filter migration and embedding in the svc/ij junction, surgical removal was not feasible. Following discharge to her home [pt] began having (on (b)(6) 2015) significant chest pain and decreased blood pressure. Transthoracic echocardiogram revealed a large pericardial effusion and collapse of the right atrium and right ventricle. A pericardial drain was implanted. Emergent surgery was performed to remove the filter and fragments. " patient outcome: "following discharge to her home [pt] began having (on (b)(6) 2015) significant chest pain and decreased blood pressure. Transthoracic echocardiogram revealed a large pericardial effusion and collapse of the right atrium and right ventricle. A pericardial drain was implanted. Emergent surgery was performed to remove the filter and fragments. " hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Summary of investigational findings: based on the limited information provided, it would be inappropriate to speculate on what may or may not have led to the reported migration and embedment of the filter in the svc/ij junction as well as the fracture (hence "fragments") nor is it possible to speculate on what may have led to the reported symptoms. 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. 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 (ivc diameter > 30 mm). 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. 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 short form complaint filed: it is alleged that "[pt] received a cook celect platinum filter on (b)(6) 2014. " "on (b)(6) 2014, [pt] had a cook celect platinum ivc filter implanted in connection with gastric sleeve surgery. On (b)(6) 2015, [pt] reported to have the filter removed. Due to filter migration and embedding in the svc/ij junction, surgical removal was not feasible. Following discharge to her home [pt] began having (on (b)(6) 2015) significant chest pain and decreased blood pressure. Transthoracic echocardiogram revealed a large pericardial effusion and collapse of the right atrium and right ventricle. A pericardial drain was implanted. Emergent surgery was performed to remove the filter and fragments. " patient outcome: "following discharge to her home [pt] began having (on (b)(6) 2015) significant chest pain and decreased blood pressure. Transthoracic echocardiogram revealed a large pericardial effusion and collapse of the right atrium and right ventricle. A pericardial drain was implanted. Emergent surgery was performed to remove the filter and fragments. " hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
Exemption number (b)(4). William cook europe aps (manufacturer) is submitting this report on behalf of(b)(4). (b)(4). (b)(6). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 09/06/2016 as follows: plaintiff allegedly received an implant on (b)(4) 2014 via the right common femoral vein due to deep vein thrombosis. Plaintiff is alleging device migration and unable to be retrieved. Plaintiff alleges vena cava perforation, bleeding and organ perforation, paralyzed diaphragm, shortness of breath and cpap, atrial fibrillation, periventricular contractions, premature atrial contractions, bradycardia syncope due to device. Plaintiff alleges attempted retrieval on (b)(6) 2015 and (b)(6) 2015 with successful retrieval via open heart surgery on (b)(6) 2015.
 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632, IN 47404
8004574500
MDR Report Key5852841
MDR Text Key117479287
Report Number3002808486-2016-00835
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121629
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 06/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date08/04/2016
Device Age6 MO
Event Location No Information
Date Manufacturer Received05/08/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/04/2014
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: 08/08/2016 Patient Sequence Number: 1
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