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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 Problems Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589)
Patient Problems Erosion (1750); Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Obstruction/Occlusion (2422); 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 number of this initial medwatch report. Initial reporter occupation: non-healthcare professional. Investigation: the following allegations have been investigated: organ/vena cava perforation, stenosis, occlusion/thrombus, tilt, erosion. 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. Unknown if the reported erosion is directly related to the filter and unable to identify a corresponding failure mode at this point in time. (b)(4) 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

The patient received an implant on (b)(6) 2012 via the right internal jugular vein to prevent deep vein thrombosis (dvt)/pulmonary embolism (pe). The patient alleges tilt, vena cava perforation, and stenosis. The patient reportedly expired on (b)(6) 2020. Specific details surrounding the patient's expiration are currently unknown, and there is currently no reported allegation of wrongful death. Death certificate has been requested but not yet received. (b)(6) 2015, per a report from venogram; ¿impression: bilateral lower extremity and ivc venogram revealed extensive thrombus extending from the popliteal vein to the ivc and superior to the infrarenal filter. Chemical tpa and heparin administered and thrombectomy/thrombolysis initiated". (b)(6) 2015, per a report from venogram; ¿impression: successful thrombolysis of the right lower extremity with in-line flow involving the femoral and iliac veins. Complete conclusion despite thrombolysis overnight of the left femoral vein. Percutaneous balloon angioplasty was performed on the occluded segments and an infusion catheter was reinserted for repeat overnight thrombolysis. The patient should return to interventional radiology on (b)(6) 2015 for subsequent treatment. Patent iliac veins and inferior vena cava. ¿ (b)(6) 2019, per a report from computed tomography; ¿findings: ivc filter has been placed within the abdomen and inferior vena cava. The tip is just below the level of the renal veins. There is minimal posterior angulation. The prongs are symmetric and intact with erosion through the ivc wall. There is no rupture. ¿ "impression: benign-appearing placement of ivc filter with no acute findings". (b)(6) 2019, per a report from computed tomography 2; ¿ivc filter with: 4 mm mesenteric perforation. Tilting with the apex against the wall. Ivc stenosis. No fracture, or migration".

 
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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)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
lissi walmann
sandet 6
bjaeverskov 4632 
56868686
MDR Report Key11832468
MDR Text Key263365807
Report Number1820334-2021-01345
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,OTHER
Reporter Occupation
Type of Report Initial
Report Date 05/17/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/17/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/01/2014
Device MODEL NumberG33016
Device Catalogue NumberIGTCFS-65-FEM
Device LOT Number2878829
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2011
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: 05/17/2021 Patient Sequence Number: 1
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