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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number EC500F
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Extrusion (2934)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Great Vessel Perforation (2152)
Event Date 09/08/2012
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: the patient was to undergo gastric bypass surgery and would be high risk for development of dvt and pe, therefore, vena cava filter placement was indicated. Using a modified seldinger technique, access was gained to the right femoral vein. A venacavagram identified the bifurcation and renal vein takeoff. The filter was successfully deployed without incident. Post procedure angiogram demonstrated the filter in good position. There were no complications. One day post filter deployment, the patient presented with right lower quadrant pain. A ct of the abdomen and pelvis demonstrated the filter with limbs extending beyond the confines of the ivc wall. No contrast extravasation was seen. Ct findings were discussed with an interventional radiologist who recommended pain treatment, a proton pump inhibitor and an office follow up. The patient was discharged same day in improved condition. Approximately two months post filter deployment, the patient was scheduled for a filter retrieval procedure. Using standard micropuncture technique, access was gained to the jugular vein. A venacavagram demonstrated the filter tilted posteriorly with the hook embedded in the ivc wall. Initial attempts to retrieve the filter using a cone retrieval device were unsuccessful. Secondary attempts made using multiple snares were unsuccessful. A 2 x 12 balloon tilted the filter to an upright position but an attempt to snare the hook was unsuccessful. Subsequent attempts using alligator forceps were unsuccessful. The decision was made to conclude the procedure. The filter remained in the same position it was initially with all of the limbs in place. There were no complications. Approximately three months post filter deployment, the patient was scheduled for another filter retrieval procedure. Using standard micropuncture technique, access was gained to the right internal jugular vein. A venacavagram demonstrated the filter at the l2-l3 level with the hook embedded in the ivc wall and limbs extending beyond the confines of the ivc wall. Multiple attempts to retrieve the filter using multiple snares were unsuccessful. Wires and catheters were used to try and free the hook and were unsuccessful. The decision was made to conclude the procedure. The filter was unchanged in position. All devices were removed and hemostasis obtained with manual compression. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the device was not returned. Images were not provided. Medical records were provided and reviewed. A vena cava filter was deployed successfully. One day post filter deployment, a ct scan demonstrated the filter with limbs extending beyond the confines of the ivc wall. Two months post filter deployment, during a schedule retrieval attempt, a venacavagram demonstrated the filter tilted posteriorly with the hook embedded in the ivc wall. Multiple attempts were made to retrieve the filter however it could not be removed. Three months post filter deployment, during another schedule retrieval attempt, venacavagram demonstrated the filter at the l2-l3 level with the hook embedded in the ivc wall and limbs extending beyond the confines of the ivc wall. Multiple attempts to retrieve the filter using multiple snares were unsuccessful. Based on the provided medical records, the investigation is confirmed for a tilted filter, perforation of the ivc, and difficulties removing the filter. Based upon the available information, the definitive root cause is unknown labeling review: the current ifu (instructions for use) states: warnings/potential complications: - movement, migration or tilt of the filter are known complications of vena cava filters. - perforation or other acute or chronic damage of the ivc wall. - filter malposition. - filter tilt. Note: it is possible that complications such as those described in the "warnings", "precautions," or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that a vena cava filter was deployed successfully, the reason for the filter deployment was not provided. No alleged deficiency with the device was reported. No other information regarding this event was provided. The patient status at this time is unknown. New information received: medical records were received and reviewed. One day post prophylactic vena cava filter deployment, the patient presented with abdominal pain. A ct scan demonstrated filter limbs extending beyond the confines of the ivc wall. There was no evidence of extravasation. The patient was discharged same day in improved condition. Approximately two months post filter deployment, during a filter retrieval procedure, the filter was found to be tilted. Despite multiple attempts using multiple devices, the filter was unable to be retrieved. There were no complications. Approximately three months post filter deployment, during a second filter retrieval procedure, multiple attempts using multiple devices to retrieve the filter were unsuccessful. The patient was hemodynamically stable at the conclusion of the procedure. No additional information surrounding this event was provided in the medical records received.
 
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Brand NameECLIPSE FILTER SYSTEM - FEMORAL
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key6177607
MDR Text Key62458004
Report Number2020394-2016-01177
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Attorney
Type of Report Initial
Report Date 02/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEC500F
Device Lot NumberUNKNOWN
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 Received12/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/15/2016 Patient Sequence Number: 1
Treatment
ADVAIR DISKUS, IRON, PROAIR HFA
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