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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G52918
Device Problems Difficult or Delayed Positioning (1157); Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Perforation of Vessels (2135)
Event Date 04/01/2017
Event Type  Injury  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Summary of investigational findings: investigation is based on event description and image review. After reported difficulties in removing the delivery system and detaching the filter, the filter was deployed in normal fashion with insignificant tilt, but because of the deployment difficulties the filter had migrated caudally. Two images showing the final position of the filter demonstrated evidence of immediate perforation by a primary filter leg, but the patient was asymptomatic. No images from filter placement was provided and the introducer system was not returned and therefore, the exact reason for the deployment difficulties encountered cannot be determined. 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. 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 medical will continue to monitor for similar events.
 
Manufacturer Narrative
(b)(4). Investigation is still in progress.
 
Event Description
Description according to initial reporter: the tulip filter was deployed in a normal fashion and appeared to release all of the legs initially. Upon attempt to remove the delivery system, the patient experienced a sharp abdominal pain. The filter migrated caudally due to leg being attached to deployment system. The physician then looked under fluro and determined that one of the four main legs had not fully detached. The physician was able to manipulate and successfully deploy the remaining leg. Upon post vena cava gram, it was evident that one of the main legs had penetrated the ivc. The patient at that time was asymptomatic (non-symptomatic) and the physician determined that the filter was best left alone at that time. The ordering physician was notified to look for any change in patient symptoms. The filter is planned for removal following surgery in the next few weeks. Patient outcome: the patient experienced an initial sharp pain which resolved and is being monitored.
 
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Brand NameGUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key6528782
MDR Text Key248275541
Report Number3002808486-2017-00976
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberG52918
Device Catalogue NumberIGTCFS-65-1-UNI-TULIP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/03/2017
Device Age3 MO
Event Location No Information
Date Manufacturer Received04/03/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/02/2017
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: 04/28/2017 Patient Sequence Number: 1
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