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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 Obstruction of Flow (2423); Structural Problem (2506); Detachment of Device or Device Component (2907)
Patient Problems Pain (1994); Great Vessel Perforation (2152)
Event Type  Injury  
Manufacturer Narrative

Manufacturer ref# (b)(4). Catalog# is unknown but referred to as cook celect filter. Occupation: non-healthcare. Summary of investigational findings: the reported allegations have been investigated based on the information provided to date. New pe 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: pulmonary embolism. Filter fracture has been reported and may be either symptomatic or asymptomatic. Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e. G. , a renal vein). Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported. Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures. 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. Unknown if the reported deformed filter and pain are directly related to the filter and unable to identify a corresponding failure mode at this point in 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. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to initial reporter: it is alleged that "on or about (b)(6) 2014, [pt] was implanted with a cook celect vena cava filter (although the records identify as a bard recovery). [pt] has underwent multiple computed tomography scan ("ct¿) scans of his abdomen and pelvis. The ct scans revealed that the cook celect filter has become occluded with blood clots causing bilateral lower extremity deep vein thrombosis and demonstrates that the apex of the cook filter is along the posterior wall with chronic ivc thrombosis and collateral veins below and above the occluded cava vein with a deformity of the cook celect filter. [pt] has also suffered perforation of the vena cava wall by all four struts of the filter with the left lateral leg perforating into the proximal left cia. The posterior left leg is perforation into anterior longitudinal ligament and periosteum of l3/l4 with exuberant periosteal reaction of the l4. Additional ct scan of [pt] chest indicates progressive chronic pulmonary emboli. [pt]¿s cook celect filter is also likely have a stress fracture of posterior right leg from acute angulation. As a result of the implanted ivc filter, [pt] has suffered post-implant pulmonary emboli, occluded filter that has caused bilateral lower extremity deep vein thrombosis, collateral veins to form and grow around the occluded and deformed filter with decrease blood flow from the lower extremities, perforation of the caval wall, possible acute fracture of strut due to filter occlusion, chest pain, back pain, abdominal pain, numbness in extremities and internal discomfort, continual medical care and monitoring and any other possible symptoms. " patient outcome: alleged that "[pt] is at risk for future cook celect filter fractures, migrations, perforations, and tilting. [pt] faces numerous health risks, including the risks of death. For the rest of his life, [pt] will require ongoing medical care and monitoring. [pt] has also suffered significant, disfiguring injuries, including significant pain and distress restricting his ability to engage in activities of daily living. ".

 
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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 (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 
56868686
MDR Report Key10423826
MDR Text Key203474303
Report Number3002808486-2020-00781
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 09/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2020
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 Received09/02/2020
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: 08/19/2020 Patient Sequence Number: 1
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