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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 Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)
Patient Problems Abdominal Pain (1685); Thrombosis (2100); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative

The previous mdr was submitted by wce under manufacturer report reference number 3002808486-2020-00239. 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. Occupation: non-healthcare professional. (b)(4). Investigation: investigation is reopened due to additional information provided. The following allegations have been investigated: vena cava perforation (grade 1 and 2); deep vein thrombus; unable to retrieve; tilt; abdominal pain. 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. Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up. The risks/benefits of filter retrieval should be considered for each patient during follow-up. Once protection from pe is no longer necessary, filter retrieval should be considered. Filter retrieval should be attempted when feasible and clinically indicated. Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e. G. , a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications). For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth. The filter is designed to be retrieved with the günther tulip vena cava filter retrieval set. It may also be retrieved with the cloversnare® vascular retriever. Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques. The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position. The safety or effectiveness of these alternative retrieval techniques has not been established. Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve. For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth. 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 abdominal pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time. A total of (b)(4) devices were manufactured in the reported lot. To date, no other complaints have been reported against the lot. The associated work order was reviewed. No related/relevant notes were documented. The device is manufactured and inspected according to current 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 14oct2011via right common femoral vein due to deep vein thrombosis (dvt). Patient is alleging tilt, vena cava perforation (grade 2 perforations x 3 ¿ all greater than 3mm and grade 1 perforation x 1) and device is unable to be retrieved. The patient further alleges abdominal pain. Per a computerized tomography (ct) scan of the abdomen and pelvis dated (b)(6) 2018, ¿findings: ivc filter in place. Proximal tip at level retroaortic left renal vein. Filter parallel with long axis ivc. Minor filter struts within ivc; inferior tip of 4 major filter struts protrude slightly extrinsic to ivc. ¿.

 
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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 Key9849752
MDR Text Key194813555
Report Number1820334-2020-00645
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 03/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/01/2014
Device MODEL NumberG33016
Device Catalogue NumberIGTCFS-65-FEM
Device LOT Number2744066
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 Manufactured05/20/2011
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: 03/18/2020 Patient Sequence Number: 1
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