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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Occlusion Within Device (1423); Malposition of Device (2616); Detachment of Device or Device Component (2907); Extrusion (2934)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Great Vessel Perforation (2152)
Event Date 03/09/2016
Event Type  Injury  
Manufacturer Narrative
No hospital or medical records have been made available to the manufacturer. As the lot number for the device was not provided, a review of the device history records is not being performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. Journal article review: a case report was provided for a complex retrieval of a vena cava filter. The patient status post t6 spinal cord injury that resulted in paraplegia during a rock climbing accident had a filter placed for recurrent deep vein thrombosis and pulmonary embolism despite anticoagulation. Approximately 11 years post filter deployment, a ct scan of the abdomen and pelvis performed for evaluation of abdominal wall cellulitis demonstrated an incidental finding of two detached filter limbs. One limb was located in a posterior basal right pulmonary artery and the other limb was extravascular abutting the aorta. Follow-up ct angiography demonstrated that the extravascular detached filter limb had likely penetrated the aorta. A high grade stenosis/occlusion of the ivc was also present with prominent collateral veins. The patient was scheduled for a filter retrieval procedure. Access was gained into the right internal jugular vein and into the left common femoral artery. Initial spot fluoroscopic images demonstrated the filter in place with two detached limbs. Venacavography demonstrated complete occlusion of the ivc at the level of the filter. Rigid bronchoscopy forceps were used to bluntly dissect the embedded apex of the filter off the caval wall and the filter was removed without incident. Venacavography again demonstrated caval occlusion at the level of the filter, but there was no evidence of an acute injury. After multiple unsuccessful attempts to retrieve the detached limb abutting the aorta with forceps, the limb was no longer visible. Fluoroscopy of the pelvis and lower extremities was performed and demonstrated embolization of the limb to the left common femoral artery. Access was gained into the right common femoral artery and the limb was retrieved with a trilobed snare from the left profundal femoris artery. A subsequent aortogram and femoral arteriogram demonstrated no significant arterial injury. The detached limb in the right pulmonary artery was successfully removed with a trilobed snare. During retrieval of that limb, the patient experienced intermittent ectopy and developed a clot within the accessed subsegmental branches of the right lower lobe. The patient tolerated the procedure well without any complications and was hospitalized overnight for observation. Knavel, e. M. , woods, m. A. , kleedehn, m. G. , ozkan, o. S. , & laeseke, p. F. (2016). Complex inferior vena cava filter retrieval complicated by migration of filter fragment into the aorta and subsequent distal embolization. Journal of vascular and interventional radiology, 27(12), 1865-1868. Http://dx. Doi. Org/10. 1016/j. Jvir. 2016. 07. 024. (b)(4). 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
An article in the journal of vascular and interventional radiology 2016 titled "complex inferior vena cava filter retrieval complicated by migration of filter fragment into the aorta and subsequent distal embolization" was reviewed. Approximately 11 years post filter deployment, an incidental finding of two detached filter limbs was identified on a ct scan. One limb was in the right pulmonary artery and the other limb was extending into the retroperitoneum abutting the aorta. The patient was scheduled for a filter retrieval procedure. Access was gained to the right internal jugular vein and to the left common femoral artery. A venacavagram demonstrated complete occlusion of the ivc at the level of the filter with no evidence of an acute injury. Forceps were then used to dissect the embedded filter apex off the caval wall and the filter was removed without incident. After multiple unsuccessful attempts to retrieve the detached limb abutting the aorta with forceps, the limb embolized to the left common femoral artery. Access was gained to the right common femoral artery and the limb was successfully retrieved with a snare. The detached limb in the right pulmonary artery was successfully retrieved with a snare. The patient tolerated the procedure well without any complications and was hospitalized overnight for observation.
 
Manufacturer Narrative
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. 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: as medical records were not provided, a review could not be performed. Image review: based on the images provided, a filter was deployed in the ivc, a detached filter arm was located in the right pulmonary artery, prior to filter retrieval a detached filter arm was located adjacent to the filter, and filter limb perforation can be confirmed. Based on the images provided, successful filter retrieval and successful retrieval of the two detached filter arms cannot be confirmed. Journal article review: a case report was provided for a complex retrieval of a vena cava filter. The patient status post t6 spinal cord injury that resulted in paraplegia during a rock climbing accident had a filter placed for recurrent deep vein thrombosis and pulmonary embolism despite anticoagulation. Approximately 11 years post filter deployment, a ct scan of the abdomen and pelvis performed for evaluation of abdominal wall cellulitis demonstrated an incidental finding of two detached filter limbs. One limb was located in a posterior basal right pulmonary artery and the other limb was extravascular abutting the aorta. Follow-up ct angiography demonstrated that the extravascular detached filter limb had likely penetrated the aorta. A high grade stenosis/occlusion of the ivc was also present with prominent collateral veins. The patient was scheduled for a filter retrieval procedure. Access was gained into the right internal jugular vein and into the left common femoral artery. Initial spot fluoroscopic images demonstrated the filter in place with two detached limbs. Venacavography demonstrated complete occlusion of the ivc at the level of the filter. Rigid bronchoscopy forceps were used to bluntly dissect the embedded apex of the filter off the caval wall and the filter was removed without incident. Venacavography again demonstrated caval occlusion at the level of the filter, but there was no evidence of an acute injury. After multiple unsuccessful attempts to retrieve the detached limb abutting the aorta with forceps, the limb was no longer visible. Fluoroscopy of the pelvis and lower extremities was performed and demonstrated embolization of the limb to the left common femoral artery. Access was gained into the right common femoral artery and the limb was retrieved with a trilobed snare from the left profundal femoris artery. A subsequent aortogram and femoral arteriogram demonstrated no significant arterial injury. The detached limb in the right pulmonary artery was successfully removed with a trilobed snare. During retrieval of that limb, the patient experienced intermittent ectopy and developed a clot within the accessed subsegmental branches of the right lower lobe. The patient tolerated the procedure well without any complications and was hospitalized overnight for observation. Knavel, e. M. , woods, m. A. , kleedehn, m. G. , ozkan, o. S. , & laeseke, p. F. (2016). Complex inferior vena cava filter retrieval complicated by migration of filter fragment into the aorta and subsequent distal embolization. Journal of vascular and interventional radiology, 27(12), 1865-1868. Http://dx. Doi. Org/10. 1016/j. Jvir. 2016. 07. 024. Conclusions: no device was returned. Images were provided and reviewed. The investigation is confirmed for detached filter limbs and perforation of the ivc wall. The investigation is inconclusive for the filter tilt. Based upon the available information, the definitive root cause for this event is unknown. Labeling review: the current ifu (instructions for use) states: warnings/potential complications: filter fracture is a known complication of vena cava filters; movement or migration of the filter is a known complication. This may be caused by placement in the ivc's with diameters exceeding the appropriate labeled dimensions specified in the ifu; perforation of other acute or chronic damage of the ivc wall. 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
An article in the journal of vascular and interventional radiology 2016 titled "complex inferior vena cava filter retrieval complicated by migration of filter fragment into the aorta and subsequent distal embolization" was reviewed. Approximately 11 years post filter deployment, an incidental finding of two detached filter limbs was identified on a ct scan. One limb was in the right pulmonary artery and the other limb was extending into the retroperitoneum abutting the aorta. The patient was scheduled for a filter retrieval procedure. Access was gained to the right internal jugular vein and to the left common femoral artery. A venacavagram demonstrated complete occlusion of the ivc at the level of the filter with no evidence of an acute injury. Forceps were then used to dissect the embedded filter apex off the caval wall and the filter was removed without incident. After multiple unsuccessful attempts to retrieve the detached limb abutting the aorta with forceps, the limb embolized to the left common femoral artery. Access was gained to the right common femoral artery and the limb was successfully retrieved with a snare. The detached limb in the right pulmonary artery was successfully retrieved with a snare. The patient tolerated the procedure well without any complications and was hospitalized overnight for observation.
 
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Brand NameRECOVERY FILTER SYSTEM
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 Key6257561
MDR Text Key64967207
Report Number2020394-2016-01290
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031328
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF048F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2017
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: 01/17/2017 Patient Sequence Number: 1
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