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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 Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Unintended Movement (3026)
Patient Problems Perforation of Vessels (2135); Stenosis (2263)
Event Type  Injury  
Manufacturer Narrative
Occupation: non-healthcare professional. Investigation: the reported allegations have been investigated based on the information provided to date. The following allegations have been investigated: vena cava perforation, migration, and tilt. 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 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. 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. Catalog # and lot # are unknown, however, 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 inferior vena cava (ivc) filter on (b)(6) 2003 and the filter subsequently perforated the patient's ivc including a grade 3 perforation of the 4 o'clock strut to abut the spine, a grade 3 perforation of the 11 o'clock strut to abut the duodenum, and a grade 2 perforation of the 3 o'clock strut of 0. 31 centimeters (cm). The filter also allegedly tilted 8. 02 degrees coronal and 9. 54 degrees in the sagittal direction with the apex of the filter abutting or extending through the anterior wall of the ivc and migrated with the apex of the filter being above the left renal vein and right renal vein confluence approximately 2 cm. 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 Key11642470
MDR Text Key244690107
Report Number1820334-2021-01111
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,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received07/14/2021
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: 04/09/2021 Patient Sequence Number: 1
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