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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Edema (1820); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263); Depression (2361); No Information (3190)
Event Date 08/01/2005
Event Type  Injury  
Manufacturer Narrative
(b)(4). Corrected data based on new information received: adverse event to product malfunction. Serious injury to malfunction. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 08/02/2017 as follows: patient allegedly received an implant on (b)(6) 2005 via the right internal jugular vein due to preoperative for total knee replacement, history of pulmonary embolism. Patient is alleging device tilt, embedded and that the device is unable to be retrieved. Patient alleges vena cava perforation due to the device. Patient alleges bard denali filter implanted on (b)(6) 2015 due to acute bilateral vein thrombus extending to the existing cook filter. Patient alleges bard denali filter was removed (b)(6) 2016. Patient alleges unsuccessful attempted, retrieval of the cook filter on (b)(6) 2016.
 
Manufacturer Narrative
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, ¿device tilt, embedded, unable to be retrieved, vena cava perforation. " cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. 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 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. 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
Additional information: investigation the following allegations have been investigated: thrombolytic therapy, thrombectomy, edema, depression, stenosis. Investigation is reopened due to additional information provided. The reported allegations have been further investigated based on the information provided to date. Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines. This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters. Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis. Unknown if the reported thrombolytic therapy, thrombectomy, edema, depression are directly related to the filter and unable to identify a corresponding failure mode at this point in time. Catalog and lot numbers are unknown, but the filter tulip is manufactured and inspected according to controls. 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 will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. This report includes information known at this time. A follow-up medwatch report will be submitted if additional relevant information become available.
 
Event Description
Patient alleges a successful, percutaneous retrieval of the cook filter on (b)(6) 2020. Patient additionally alleges depression. Per the report from computerized tomography (ct): "the patient has an ivc filter with the hook adjacent to the posterior wall of the inferior vena cava. Minimal thrombus is seen within the cone of the filter. The previously noted thrombus below the filter and adjacent to the wall of the inferior vena cava is no longer apparent". "no iliac vein thrombus is seen. The common femoral veins are also patent. The previously noted left common femoral vein thrombus has also resolved". Per the retrieval report (successful): "the ivc gram demonstrates minimal thrombus/fibrin within the cone for the ivc filter. 3 filter struts appear to be projecting beyond the wall of the inferior vena cava. " "the filter was subsequently removed. " "an ivc gram was obtained post filter extraction demonstrating mild wall irregularity within the inferior vena cava. No extravasation was noted".
 
Manufacturer Narrative
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 "tulip: tilt, embedded, unable to retrieve, vc perforation, dvt, occlusive thrombus- updated sfc. " cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. 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. A filter that is embedded in the wall of the ivc may be difficult to retrieve. 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. 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. Ivc filter thrombus, or clot in ivc filter, is an outcome where the filter has either entrapped a clot that has embolized from an upstream source, such as a deep vein thrombus, or where a clot has formed on or within the filter. Filter thrombus can either resolve through the process of thrombolysis, remain stationary without subsequent sequelae, or alternatively provide a nidus for additional clot formation. The presence of a filter thrombus could preclude the removal of the filter during a retrieval process due to potential dislodgement of the thrombus which could cause a downstream occlusive event, e. G. Pulmonary embolism. Ivc filter thrombus is documented by ultrasound (us), ct, mr imaging or venography. Unknown if the reported dvt is directly related to the filter. Product catalog and lot# are unknown, but the filter tulip 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.
 
Event Description
No additional information provided at this time.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
It is alleged that [pt] received a cook gunther tulip on (b)(6) 2005. It is alleged that the patient 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)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC.
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6774624
MDR Text Key210988775
Report Number1820334-2017-02258
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,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot 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 Received01/06/2021
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: 08/08/2017 Patient Sequence Number: 1
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