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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 Material Erosion (1214); Detachment of Device or Device Component (2907); Extrusion (2934)
Patient Problems Perforation (2001); Great Vessel Perforation (2152); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 09/07/2013
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. Investigation summary: neither the device nor images were returned. Medical records were provided. The medical records allege that ct imaging demonstrated five limbs perforating the ivc wall approximately nine years after implantation. One limb was allegedly approximating the posterior wall of the aorta. Allegedly, exploratory laparotomy was performed. The struts of the filter were reportedly sticking through the vena cava into the aorta and surrounding tissues. The struts were cut and the filter was removed successfully. A second filter was allegedly implanted percutaneously above the level of the repair. Based on the medical record review, limb perforation of the ivc can be confirmed. However, the investigation is inconclusive for the alleged filter limb detachment. 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: - 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. - filter fracture is a known complication of vena cava filters. There have been reports for embolization of vena cava filter fragments resulting in retrieval of fragment using endovascular and/or surgical techniques. Most cases of the filter fracture, however, have been reported without any adverse clinical sequelae. - perforation of other acute or chronic damage of the ivc wall.
 
Event Description
It was reported that a vena cava filter was deployed successfully in a patient with a history of recurrent deep vein thrombosis with pulmonary embolus. The pulmonary embolus occurred while the patient was fully anticoagulated prior to the filter deployment. Nine years post deployment, a ct scan revealed that five arms of the ivc filter were identified eroding through the ivc wall. Exploratory laparotomy was performed; and the filter was removed. Another vena cava filter was deployed successfully. The patient tolerated the procedure well. New information received: it was reported through the litigation process that some time post filter deployment, filter limbs allegedly detached and embolized to the lungs. Additionally, limb(s) allegedly perforated into organs. Reportedly, the filter was successfully retrieved via an open abdominal procedure, no attempts were made to retrieve the detached limbs.
 
Manufacturer Narrative
No medical images have been provided to the manufacturer. The device was not sent back to the manufacturer for evaluation. A review of the device history records could not be performed as the lot number for the device was not provided. Medical records were received and reviewed and the investigation of the reported event is currently underway. Medical record review: the patient had a history of recurrent deep vein thrombosis of the lower extremities with pulmonary embolus. The pulmonary embolus occurred while the patient was fully anticoagulated, representing failure of anticoagulation. The patient was diagnosed with unknown coagulopathy. Therefore, on (b)(6) 2004, an inferior vena cava filter was deployed. Nine years later, a ct scan of the abdomen and pelvis revealed that five arms of the ivc filter had eroded through the ivc wall. One of the arms was seen approximating the posterior wall of the aorta. A metallic density was also seen at the level appendix, likely representing surgical clips. A ct scan of the chest revealed a linear metallic density seen in the right inferior segmental artery. On (b)(6) 2013, an exploratory laparotomy was performed and an inferior vena cava venotomy and inferior vena cava filter removal was necessary. The filter was removed successfully, there was no mention of a missing filter limb from the procedure. An accidental puncture occurred at the bifurcation of the right and left common iliac vein and the inferior vena cava. The hole was repaired. Percutaneous placement of a greenfield ivc filter was performed. The patient tolerated the procedure well and was discharged to home two days later. No further information was available.
 
Event Description
It was reported that a vena cava filter was deployed successfully in a patient with a history of recurrent deep vein thrombosis with pulmonary embolus. The pulmonary embolus occurred while the patient was fully anticoagulated prior to the filter deployment. Nine years post deployment, a ct scan revealed that five arms of the ivc filter were identified eroding through the ivc wall. Exploratory laparotomy was performed; and the filter was removed. Another vena cava filter was deployed successfully. The patient tolerated the procedure well.
 
Manufacturer Narrative
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. Image/photo review: no images or photos have been made available to the manufacturer. Conclusion: neither the device nor images were returned. Medical records were provided. The medical records allege that ct imaging demonstrated five limbs perforating the ivc wall approximately nine years after implantation. One limb was allegedly approximating the posterior wall of the aorta. Allegedly, exploratory laparotomy was performed. The struts of the filter were reportedly sticking through the vena cava into the aorta and surrounding tissues. The struts were cut and the filter was removed successfully. A second filter was allegedly implanted percutaneously above the level of the repair. Based on the medical record review, limb perforation of the ivc can be confirmed. Based upon the available information the definitive root cause for this event is unknown. Labeling review: the current ifu (instructions for use) states: potential complications: perforation or other acute or chronic damage of the ivc wall. All these above complications have been associated with serious adverse events such as medical intervention and/or death. The risk/benefit ratio of any of these complications should be weighed against the inherent risk/benefit ratio for a patient who is at risk of pulmonary embolism without intervention.
 
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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 Key5502743
MDR Text Key252104100
Report Number2020394-2016-00265
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2016
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2017
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: 03/15/2016 Patient Sequence Number: 1
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