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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
Model Number G33017
Device Problems Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589)
Patient Problems Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative

The previous mdr was submitted by william cook europe under manufacturer report reference number 3002808486-2020-00690. Additional information provided determined that this device was manufactured by cook inc (cinc). With the submission of this initial report, cinc informs that all future submissions regarding this complaint will be handled under manufacturer report number referenced in this initial medwatch report. Reporter occupation: non-healthcare professional. Investigation: the following allegations have been investigated: organ/vena cava perforation, ivc thrombosis, tilt. 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. 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. A total of (b)(4) devices were manufactured in the reported lot. To date, one additional complaint has been reported against this lot. The associated work order was reviewed. No related/relevant notes were documented. The device 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 report will be submitted should additional information become available.

 
Event Description

Patient allegedly received an implant on via the right internal jugular vein due to saddle embolus, limited cardiopulmonary reserve, bilateral lower extremity deep vein thrombosis (dvt). It is alleged the filter was successfully retrieved (b)(6) 2019. Patient is alleging device tilt, vena cava and organ perforation and chronic thrombosis of the inferior vena cava (ivc). Per a (b)(6) 2018 computed tomography (ct) abdomen without contrast: "ivc filter with superior tip distal to the level of the left renal vein. 15 degrees rightward tilt of the superior ivc filter. No filter fracture. Left anterior strut projects within the pericaval fat abutting the right aspect of the aorta without findings of aortic perforation as on axial image 41 of 52. Anteroinferior strut projects within the pancreatic parenchyma as on axial image 42 of 52. Right inferior strut projects within the pericaval fat as on coronal image 26 of 50".

 
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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 Key10405481
MDR Text Key203669569
Report Number1820334-2020-01491
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
Reporter Occupation
Type of Report Initial
Report Date 08/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/01/2015
Device MODEL NumberG33017
Device Catalogue NumberIGTCFS-65-JUG
Device LOT Number3953833
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/11/2013
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: 08/13/2020 Patient Sequence Number: 1
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