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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF310F
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Detachment of Device or Device Component (2907)
Patient Problems Pulmonary Embolism (1498); Device Embedded In Tissue or Plaque (3165)
Event Date 10/03/2006
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: a vena cava filter was indicated for an upcoming urologic surgery in the patient with a history of deep venous thrombosis. The right groin was prepped and draped sterilely. A percutaneous puncture of the right common femoral vein was performed easily. A 5 french sheath was inserted over a bentson wire. Hand injection tomography was then performed which demonstrated symmetrical location of the renal veins with inflow at the l1-2 vertebral interspace and no evidence of venous anomaly or thrombosis identified. The filter was successfully deployed infrarenal without difficulty with the tip just above the top of l2. The patient tolerated the procedure well and was transferred in stable condition. Approximately six weeks post filter deployment, chest ct demonstrated findings suggestive of acute on chronic pulmonary emboli. Approximately seven years post deployment, the patient sustained injuries following a motor vehicle accident which required orthopedic intervention. As a result, the patient consulted vascular surgery with concern regarding going off anticoagulation given his prior pulmonary embolus. The patient was asymptomatic, but inquired if a second filter would be beneficial. Approximately seven years one month post filter deployment, the patient presented for filter retrieval and replacement following a review of previous ct exams which revealed a tilted caval filter with a sizable hemi azygos vein that entered with the circumaortic left renal vein into the ivc at the level of the filter. It was felt this most likely represented the pathway of the patient¿s recurrent pulmonary embolism. The neck was prepped and draped in the usual manner and jugular access was obtained. Cavogram performed noted no significant thrombus. Extensive effort using a snare followed by biopsy forceps was required until ultimately the snare was successful in capturing and retrieving the filter. A follow-up cavogram showed no significant contrast extravasation noted. Another manufacturer¿s ivc filter was then placed more inferiorly in the ivc just above the iliac vein in excellent position. The sheath was removed and hemostasis was obtained. Approximately two years four months post filter retrieval, a chest ct report for retained foreign body fragments indicated that one or more limbs of the tilted filter detached at the time of retrieval. The report identified what appeared to be a linear metallic fragment (not present on prior exams) in the right lower hilum at its junction within the mediastinum and not within the vessel. This was closest to the left atrium. There was also a small metallic fragment against the medial left apex of the lung which was present on a prior chest ct. The patient was reported to be asymptomatic both at the time of the ct report and more than three years prior. Approximately two months later, the patient had a ct for hemoptysis and the filter fragments were found to be without surrounding inflammation and in stable position. The report noted that the radiologist discussed the findings with the patient regarding the filter fragments, reassuring that the fragments were not causing the hemoptysis, adding that they would likely never cause any trouble. 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. Six weeks post successful filter deployment, chest ct demonstrated findings suggestive of acute chronic pulmonary emboli. Seven years post deployment, the patient sustained injuries following a motor vehicle accident which required orthopedic intervention. One month post filter later, the patient presented for filter retrieval and replacement following a review of previous ct exams which revealed a tilted caval filter. Extensive effort using a snare followed by biopsy forceps was required until ultimately the snare was successful in capturing and retrieving the filter. It was noted that the filter was intact at the time that it was retrieved. Another manufacturer¿s ivc filter was then placed more inferiorly in the ivc just above the iliac vein in excellent position. Approximately two years and four months post filter retrieval, a chest ct report for retained foreign body fragments indicated that one or more limbs were detached. However, to which limb the filter belonged was not confirmed. Based on the provided medical records, the investigation is confirmed for a tilted filter and difficulties removing the filter. It can also be confirmed that there was pe after filter implantation. However, the investigation is inconclusive for the detached filter limbs as the limbs were not confirmed to belong to the bard filter. Per the provided medical records, a sizable hemi azygos vein entered with the circumaortic left renal vein into the ivc at the level of the filter. It was felt this most likely represented the pathway of the patient¿s recurrent pulmonary embolism. Additionally, it was noted the patient was involved in a motor vehicle accident after filter implantation. Per the instructions for use, open abdominal procedures may affect the integrity and stability of the filter. The impact associated with a motor vehicle accident could have the same as open procedure in regards to the integrity and stability of the filter. Therefore, the noted filter tilt may be attributed to the accident. The removal difficulties were most likely a result of the tilted filter. However, the definitive root cause cannot be determined. Labeling review: the current ifu (instructions for use) states: warnings/potential complications: filter fractures are a known complication of vena cava filters. There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques; 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 tilt; filter malposition; acute or recurrent pulmonary embolism. This has been reported despite filter usage. It is not known if thrombi passed through the filter, or originated from superior or collateral vessel. All of the above complications have been associated with serious adverse events such as medical intervention and/or death. 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. Approximately six weeks post vena cava filter deployment, chest ct demonstrated pulmonary emboli. Approximately seven years one month post deployment, the patient presented for filter retrieval and replacement. Ct demonstrated filter tilt prior to retrieval. Multiple attempts using forceps and a snare were required to successfully retrieve the filter. Another manufacturer¿s ivc filter was then placed more inferiorly in the ivc just above the iliac vein in excellent position. The patient was hemodynamically stable at the conclusion. Approximately nine years five months post filter deployment, ct performed for retained foreign fragments demonstrated what appeared to be a linear metallic fragment in the right lower hilum at its junction within the mediastinum and not within the vessel. There was also a small metallic fragment against the medial left apex of the lung, seen on the patient's prior chest ct. It was additionally documented that one or more limbs of the tilted filter detached at the time of retrieval. The patient was reported to be asymptomatic at the time of report in addition to more three years prior. Approximately two months later, the patient had a ct for hemoptysis which identified the filter fragments to be stable and not the cause of hemoptysis. No additional medical records were received for this patient.
 
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Brand NameG2 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
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key6156814
MDR Text Key61848961
Report Number2020394-2016-01148
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062887
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 06/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF310F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2020
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: 12/08/2016 Patient Sequence Number: 1
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