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U.S. Department of Health and Human Services

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

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COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G33016
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Dyspnea (1816); Internal Organ Perforation (1987); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2020-00283. Occupation: non-healthcare professional. (b)(4). Investigation: the following allegations have been investigated: vena cava (vc)/organ perforation, tilt, shortness of breath, fear, worry, stress. 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. 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. Unknown if the reported shortness of breath, fear, worry, and stress are directly related to the filter and unable to identify a corresponding failure mode at this point in time. 20 devices in lot. No relevant notes on work order. The product 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

Patient allegedly received an implant on (b)(6) 2013 due to a stroke. Patient is alleging vena cava/ organ perforation and tilt. The patient is further alleging fear, worry, stress, and shortness of breath. (b)(6) 2019, per a report from computed tomography (ct); ¿findings: axial ct abdomen and pelvis with coronal and sagittal reformatted images were submitted for review on (b)(6) 2020 of the ivc, filter position, and related findings. The hook of the cook gunther tulip retrievable ivc filter is at the l1-2 interspace. The ivc filter is tilted anteriorly and medially and the hook contacts the ivc wall. All the struts of the ivc filter perforate the ivc up to 11mm. One (1) anterior strut perforates the ivc wall 9mm and contacts the bowel. One (1) medial strut perforates the ivc wall 11mm and contacts the aorta. One (1) posterior strut perforates the ivc wall 11mm and resides within the soft tissues. One (1) lateral strut perforates the ivc wall 4mm and contacts the bowel. No hemorrhage seen. No thrombus is seen within the ivc. No fracture fragments are identified. Impression: infrarenal ivc filter perforating through the ivc with multiple struts extending extraluminal as described above. The above mentioned ivc filter is considered temporary and removable. Therefore, further evaluation with interventional radiology is recommended for possible intervention. ¿.

 
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Brand NameGUNTHER TULIP FEMORAL 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 Key9856537
MDR Text Key196434681
Report Number1820334-2020-00651
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK043509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 03/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/01/2016
Device MODEL NumberG33016
Device Catalogue NumberIGTCFS-65-FEM
Device LOT Number4075553
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2013
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: 03/19/2020 Patient Sequence Number: 1
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