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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
Catalog Number IGTCFS-65-FEM
Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Patient Problems Internal Organ Perforation (1987); Perforation (2001); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
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 ¿organ perforation, vena cava perforation, tilt, device is unable to be removed". 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 tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period. 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. According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e. G. , the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu.
 
Manufacturer Narrative
*** william cook europe initially reported event under mfr report # 3002808486-2016-00023. New information was received identifying that the product was a cook inc. Manufactured device. An updated emdr report was submitted under cook inc. Mfr report # 1820334-2016-00681, follow up # 1. This was in reference to william cook europe mfr report # 3002808486-2016-00023. Cook is now submitting an initial report to correct this issue. **** (b)(4). Evaluation- the product was not returned to assist with the investigation. No notes of relevance found in the device work order, nor on the filter lot number. No other complaints have been received relevant to this lot. Impossible to comment on the alleged injuries. Device manufactured/inspected according to specifications. There is no evidence to suggest the device was not manufactured to specifications. No evidence to suggest a device failure. We have notified appropriate personnel and will continue to monitor for similar events. If additional information is received, the report will be reopened for further investigation.
 
Event Description
It is alleged that patient received a cook gunther tulip filter on (b)(6) 2010 at (b)(6). It is alleged that the patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
Initial mdr was submitted by william cook europe under reference # 3002808486-2016-00023. Additional information provided on 07/06/2016 determined this device was manufactured by cinc. Evaluation: the product was not returned to assist with the investigation. No notes of relevance found in the device work order, nor on the filter lot number. No other complaints have been received relevant to this lot. Impossible to comment on the alleged injuries. Device manufactured/inspected according to specifications. There is no evidence to suggest the device was not manufactured to specifications. No evidence to suggest a device failure. We have notified appropriate personnel and will continue to monitor for similar events. If additional information is received, the report will be reopened for further investigation.
 
Event Description
It is alleged that patient received a cook gunther tulip filter on (b)(6) 2010 at (b)(6) health system. The filter was placed by dr. (b)(6). It is alleged that the patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
Acute damage to the inferior vena cava is listed as a potential adverse event in the ifu. (b)(4). The event is currently under evaluation. A supplemental report will be submitted upon completion.
 
Event Description
It is alleged that patient received a cook gunther tulip filter on (b)(6) 2010 at the (b)(6). It is alleged that the patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided. Additional information received january 30, 2017: it is alleged in the pending lawsuit that pt suffers from vena cava perforation, the inability to retrieve the device, bleeding, organ perforation, and other: lupus coagulation present in blood; on blood thinners for lifetime.
 
Manufacturer Narrative
(b)(4). According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e. G. , the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu. It has not been possible to fully investigate or evaluate this event based on the limited information provided to date. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
Additional information received (b)(6) 2017: it is alleged in the pending lawsuit that pt suffers from vena cava perforation, the inability to retrieve the device, bleeding, organ perforation, and other: lupus coagulation present in blood; on blood thinners for lifetime.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 02/01/2016 as follows: the plaintiff allegedly received the device implant on (b)(6) 2010 via right femoral vein due to pe, dvt, and as prophylactic arising from transfusion. Plaintiff is alleging organ perforation - duodenum, vena cava perforation, bleeding, pain, lupus coagulation, long term medications are required, device tilt, device is unable to be retrieved.
 
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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
8123392235
MDR Report Key5834703
MDR Text Key114561419
Report Number1820334-2016-00681
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/23/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2010
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: 07/29/2016 Patient Sequence Number: 1
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