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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 Fracture (1260); Malposition of Device (2616); Appropriate Term/Code Not Available (3191)
Patient Problem Internal Organ Perforation (1987)
Event Type  Injury  
Manufacturer Narrative

Manufacturer 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. 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. Filter tilt has been reported. Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt. Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency. Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt. 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 patient received a cook celect filter on (b)(6) 2013. The patient reportedly experienced filter fracture, organ/ vena cava perforation by the filter, and filter tilt. Ct (computed tomography): "inferior vena cava filter at the level of the renal veins with multiple prongs extending to the caval wall and into the surrounding structures, including a prong piercing the anterior inferior parenchyma of the right kidney with an area decreased surrounding enhancement. " "there is an inferior vena cava filter at the level of the renal veins. Two of the posterior prongs extend through the cava wall into the ipsilateral psoas muscle. Two of the right-sided prongs extend and terminate in the right renal vein. One of the right-sided prong extends through the caval wall and into the parenchyma of the anterior inferior kidney. The surrounding parenchyma demonstrates decreased enhancement around this prong. In addition, there is an anterior prong which extends through the anterior portion of the caval wall. There is a left-sided prong which extends to the caval wall and into the prevertebral soft tissues. " successful retrieval report: "scout images demonstrated a tilted ivc filter with 2 struts with caval penetration. " "post filter removal venogram did not demonstrate extravasation. " "scout images of the chest and abdomen did not demonstrate evidence for any retained filter fragments. " "tilted infrarenal celect ivc filter with leg perforating into the right renal parenchyma. One upper stabilizing strut is fractured. Successful removal of indwelling ivc filter in its entirety using endobronchial forceps. The fragment was removed as well separately using forceps. ".

 
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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 
MDR Report Key9846657
MDR Text Key184465825
Report Number3002808486-2020-00331
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
Report Date 03/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/18/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2020
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: 03/18/2020 Patient Sequence Number: 1
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