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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 N/A
Device Problems Material Erosion (1214); Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Internal Organ Perforation (1987); Perforation of Vessels (2135); No Information (3190)
Event Type  Injury  
Manufacturer Narrative

(b)(4). The event is currently under investigation. A supplemental report will be submitted upon completion.

 
Event Description

It is alleged that the plaintiff received a gunther filter on (b)(6) 2007. It is alleged that the plaintiff was injured without further explanation. Hospital and medical records have been requested but not yet provided.

 
Manufacturer Narrative

(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

This additional information received on 10/31/2017 as follows: patient received an implant on (b)(6) 2007 via the right common femoral vein due to motor vehicle accident with cerebral artifacts. Patient experiences vena cava perforation, embedded and prongs eroded into the duodenum and pancreas. Patient experienced exploratory laparotomy excision of the prongs that had eroded into the duodenum and pancreas. Patient is alleging severe abdominal pain, limited mobility at times and fear due to the device. Patient alleges that the device cannot be retrieved. Retrieval was attempted on (b)(6) 2007. Patient experienced a partial removal on (b)(6) 2011.

 
Manufacturer Narrative

Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'vc, duodenum and pancreas perforation, embedded, laparotomy excision of prongs, pain, cannot be retrieved'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Vena cava wall perforation is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e. G. , a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter. There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae. E. G. Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae. In contrast, perforation of adjacent organs is reported with clinical sequelae. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs. Complex. Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques. No relevant notes found in device work order. No other complaints found in device lot. Product is manufactured and inspected according to manufacturing instructions and quality control. 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.

 
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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 Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6954181
MDR Text Key89472332
Report Number1820334-2017-03607
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 ATTORNEY
Type of Report Initial,Followup,Followup
Report Date 12/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberIGTCFS-65-FEM
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/28/2007
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: 10/17/2017 Patient Sequence Number: 1
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