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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-UNI-CELECT-PT
Device Problems Difficult to Remove (1528); Structural Problem (2506); Detachment of Device or Device Component (2907); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)
Patient Problems Pulmonary Embolism (1498); Internal Organ Perforation (1987); Pain (1994); Thrombosis (2100); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative

Manufacturers ref# (b)(4). Catalog# is unknown but referred to as cook celect filter. Occupation: non-healthcare professional. (b)(4). 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 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. Unknown if the reported pain is 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 medical will continue to monitor for similar events.

 
Event Description

Description of event according to initial reporter: it is alleged that "[pt] received a cook celect filter on (b)(6) 2016. Hospital and medical records have been requested but not yet provided. On or about (b)(6) 2017 [pt] experienced severe pain in his leg, which required a 3-day hospitalization while on a business trip. During this admission, he was diagnosed and treated for an occlusive thrombus which extended from the mid-femoral vain all the way to the popliteal vein; bilateral pulmonary embolisms; as well as heart strain caused by the aforementioned pulmonary embolisms. On or about (b)(6) 2018, the ivc filter was attempted to be removed from [pt]; this retrieval attempt was unsuccessful. On or about (b)(6) 2019, ct imaging showed at least one ivc filter "arm" perforating outside of the inferior vena cava lumen in [pt]. On or about (b)(6) 2019, [pt] underwent his second unsuccessful filter retrieval attempt. Ultimately, [pt] was referred to another hospital for exploration of further surgical removal options, which is ongoing. " patient outcome: it is alleged that "as a direct and proximate result of having the ivc filter implanted in him, [pt] has suffered permanent and continuous injuries, pain and suffering, disability and impairment. [pt] has suffered emotional trauma, harm and injuries that will continue to be so diminished into the future. Furthermore, [pt] has lost earnings and will continue to lose earnings into the future and have medical bills both past and future related to care because of the ivc filters defects. ".

 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN UNISET 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 
MDR Report Key9915299
MDR Text Key186340549
Report Number3002808486-2020-00386
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/14/2019
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT-PT
Device LOT NumberE3428157
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 Received04/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/14/2016
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: 04/02/2020 Patient Sequence Number: 1
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