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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
Catalog Number UNKNOWN
Device Problems Difficult to Remove (1528); Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506); Unintended Movement (3026)
Patient Problems Anemia (1706); Internal Organ Perforation (1987); Sepsis (2067); Thrombus (2101); Perforation of Vessels (2135); Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative

Initial reporter occupation: non-healthcare professional. Investigation: the reported allegations have been investigated based on the information provided to date. The following allegations have been investigated: organ/ vena cava perforation, inferior vena cava thrombus, hospitalization for new onset bilateral deep vein thrombus , inability to retrieve, migration, acute kidney injury/blood loss anemia, sepsis secondary to ivc thrombus infection, hypovolemic shock, lifelong anti-coagulation medication, pain, disability, and impairment. Filter interacts with ivc wall, e. G. Penetration/perforation/embedment. This may be either symptomatic or asymptomatic. Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration. 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. Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up. The risks/benefits of filter retrieval should be considered for each patient during follow-up. Once protection from pe is no longer necessary, filter retrieval should be considered. Filter retrieval should be attempted when feasible and clinically indicated. Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e. G. , a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications). For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth. The filter is designed to be retrieved with the günther tulip vena cava filter retrieval set. It may also be retrieved with the cloversnare® vascular retriever. Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques. The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position. The safety or effectiveness of these alternative retrieval techniques has not been established. Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve. For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth. Filter or filter fragment migration and (or) embolization (e. G. , movement to the heart or lungs) has been reported. Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic. Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; and (or) excessive force or manipulations near an in situ filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Potential adverse events that may occur include, but are not limited to, the following: filter migration, trauma to adjacent structures. Unknown if the reported acute kidney injury/blood loss anemia, sepsis secondary to ivc thrombus infection, hypovolemic shock, lifelong anti-coagulation medication, pain, disability, and impairment are directly related to the filter and unable to identify a corresponding failure mode at this point in time. Catalog and lot number are unknown. The alleged 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. 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 becomes available.

 
Event Description

The following information is alleged: the patient received a gunther tulip on ( b)(6) 2008. The patient experienced hospitalization for new onset bilateral deep vein thrombi (dvt) of the proximal veins in [the] lower extremities, inferior vena cava (ivc) thrombus, acute kidney injury, acute blood loss anemia, sepsis secondary to ivc thrombus infection, hypovolemic shock, migration of the ivc filter beyond the wall of the ivc with one leg extending 4mm into the l3 vertebral body, another leg adjacent to posterior wall of the abdominal aorta posing aortic perforation risk and an anterior leg extending adjacent to the distal duodenum posing risk of duodenal perforation or peritonitis, with unsuccessful percutaneous removal attempts through the right internal jugular [vein] approximately 10 years and 6 months later and approximately 11 years and 11 months later that required an open removal of the cook [gunther] tulip ivc filter with inferior vena cava venotomy and endophlebectomy, primary closure inferior vena cava and lysis of adhesions, resulting in the patient taking lifelong anti-coagulation medication, pain, disability, and impairment. 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 Key10275341
MDR Text Key198858065
Report Number1820334-2020-01298
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
Type of Report Initial,Followup
Report Date 09/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received08/31/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 07/15/2020 Patient Sequence Number: 1
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