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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-UNI-CELECT-PERM
Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Death (1802); Hemorrhage/Bleeding (1888); Perforation (2001); Perforation of Vessels (2135)
Event Date 12/15/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). Catalog# unknown as information was not provided but refered to as a cook celect filter. Lot# unknown as information was not provided. Expiration date unknown as lot# is unknown. As catalog# is unknown it could be either k061815, k073374, k090140, k112119, k121057 or k121629. Investigation is still in progress.

 
Event Description

Description according to complainant: it is alleged that "[pt] was implanted with cook celect filter on (b)(6) 2013 at the university medical center of southern nevada. The celect filter was properly deployed and confirmed to be in "good position" after placement. The device subsequently failed and tore multiple holes in vena cava resulting in massive internal bleeding and death on (b)(6) 2015. An autopsy confirmed that [pt] bled to death as a result of the filter piercing his vena cava, which led to massive internal bleeding from his vena cava. " patient outcome: it is alleged that "[pt] bled to death as a result of the filter piercing his vena cava, which led to massive internal bleeding from his vena cava. ".

 
Manufacturer Narrative

(b)(4) catalog# unknown as information was not provided but refered to as a cook celect filter. Lot# unknown as information was not provided. Expiration date unknown as lot# is unknown. As catalog# is unknown it could be either k061815, k073374, k090140, k112119, k121057 or k121629. Summary of investigational findings: 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. However, without imaging and only limited information available, it is not possible to comment on the alleged perforation and consequently death. 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 "[pt] was implanted with cook celect filter on (b)(6) 2013 at the university medical center of southern nevada. The celect filter was properly deployed and confirmed to be in "good position" after placement. The device subsequently failed and tore multiple holes in vena cava resulting in massive internal bleeding and death on (b)(6) 2015. An autopsy confirmed that [pt] bled to death as a result of the filter piercing his vena cava, which led to massive internal bleeding from his vena cava. " patient outcome: it is alleged that "[pt] bled to death as a result of the filter piercing his vena cava, which led to massive internal bleeding from his vena cava. ".

 
Manufacturer Narrative

(b)(4). William cook (b)(4) is not assuming responsibility for patient death, unclear the reason for death. (b)(4). Name and address for importer site: (b)(4). The patient involved was reported to be deceased without further details, therefore this report is being submitted as ¿death¿ related as a cautionary measure. The event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

This additional information was received on 04/05/2016 as follows: the patient allegedly received the filter implant via left internal jugular vein on (b)(6)2013. The device allegedly subsequently failed and allegedly tore multiple holes in vena cava resulting in massive internal bleeding and death on (b)(6)2015. An autopsy reported that the patient bled to death as a result of the filter piercing his vena cava, which led to massive internal bleeding from his vena cava.

 
Manufacturer Narrative

Manufacturer ref# (b)(4). William cook europe is not assuming responsibility for patient death, unclear the reason for death. It is alleged that "[pt] was implanted with cook celect filter on (b)(6) 2013 at (b)(6). The celect filter was properly deployed and confirmed to be in "good position" after placement. The device subsequently failed and tore multiple holes in vena cava resulting in massive internal bleeding and death on (b)(6) 2015. An autopsy confirmed that [pt] bled to death as a result of the filter piercing his vena cava, which led to massive internal bleeding from his vena cava". It is alleged that "[pt] bled to death as a result of the filter piercing his vena cava, which led to massive internal bleeding from his vena cava". 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. 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. However, without imaging and only limited information available, it is impossible to comment on the alleged perforation and consequently death. 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). Blank fields on this form indicate the information is unknown or unavailable, or unchanged. (b)(6). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

 
Manufacturer Narrative

(b)(4). Additional information: investigation: investigation is reopened due to additional information provided. 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 causing bleeding, death". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Unknown if reported patient death is related to filter. 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 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.

 
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Brand NameCOOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER
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 Key5362533
MDR Text Key35753454
Report Number3002808486-2016-00011
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK073374
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,Followup
Report Date 02/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/15/2015
Device Catalogue NumberIGTCFS-65-UNI-CELECT-PERM
Device LOT NumberE3032069
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/28/2015
Device Age3 yr
Event Location No Information
Date Manufacturer Received01/20/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2013
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: 01/13/2016 Patient Sequence Number: 1
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