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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JUG
Device Problems Obstruction of Flow (2423); Structural Problem (2506)
Patient Problems Perforation of Vessels (2135); Thrombosis/Thrombus (4440)
Event Type  Injury  
Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference# (b)(4). Additional information provided determined that this device was manufactured by cook inc. With the submission of this initial medwatch report, cook inc. Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference # referenced in this initial medwatch report. Initial reporter occupation: non-healthcare professional. Investigation: the following allegations have been investigated: vena cava perforation deep vein thrombus, and limited mobility. Investigation is reopened due to additional information provided. The reported allegations have been further investigated based on the information provided to date. 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 limited mobility is directly related to the filter and unable to identify a corresponding failure mode at this point in time. Lot number is unknown. The alleged tulip is manufactured and inspected according to controls. 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

Patient allegedly received an implant on (b)(6) 2015 due to deep vein thrombosis (dvt)/pulmonary embolism (pe). The patient alleged vena cava perforation. The patient further alleged limited mobility and post implant dvt.

 
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Brand NameGUNTHER TULIP JUGULAR VENA CAVA FILTER SET
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 Key12282979
MDR Text Key265244759
Report Number1820334-2021-01927
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/05/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-JUG
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 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: 08/05/2021 Patient Sequence Number: 1
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