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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 Problem Pain (1994)
Event Date 10/01/2018
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: a device history record review could not be performed as the lot number is unknown. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately eleven years and nine months post filter deployment, a computed tomography revealed the filter was tilted anteriorly to the right by 13 degrees relative to the long axis of the inferior vena cava and 22 degrees relative to the vertical axis. The upper tip of the filter was located near the anterior inferior vena cava wall and situated 3 cm below the confluence of the renal veins. The longer metallic struts of the filter were situated near the inferior vena cava bifurcation. A right posterior strut contacted the anterior superior margin of the vertebral body with focal sclerosis/osteophyte. A left anterior strut was located near the posterior wall of the right common iliac artery. Several of the metallic struts projected outside of the inferior vena cava wall by up to 1 cm in length and 3 to 4 mm in the transverse plane. The filter appeared to be tilted and a posterior strut may be embedded in the anterior margin of vertebra. Anterior strut contacted the posterior wall of the right common iliac artery. Tilt of the filter with protrusion of the legs into the iliac artery and spine was noted. The location of the struts, one of which was touched the iliac artery but does not appeared to penetrate the lumen. There was also a strut protruded toward the spine. The patient had experienced back pain. Eventually five months later the patient presented with abdominal pain. Subsequently filter retrieval was performed. A 6-french sheath was passed initially and attempted to snare the top of the filter; however, it was stuck to the side of the cava and could not be engaged. Then used a sos omni catheter and a glidewire and flipped through the interstices. Once looped through the filter, snared the end of the wire and controlled both ends of the wire and advanced the sheath downward release the filter. It did not fully enter the sheath. It was brought up and retrieved with the feet extending slightly through the end of the sheath. The filter gross examination revealed an aggregate of pink and red soft tissue attached to the filter with 12 prongs. Therefore, the investigation is confirmed for the perforation of the ivc, filter tilt and retrieval difficulties. However, the investigation is inconclusive for the filter limb detachment. Based on the available information, the definitive root cause is unknown. Labeling review: the current instructions for use states: warnings: filter removal: use only the bard recovery cone removal system (packaged separately) to retrieve the filter. Use of other removal devices has resulted in recurrent pulmonary embolism. A review of product labeling documents (e. G. Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate. (device: 4001).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism. At some time post filter deployment, it was alleged that filter struts detached and perforated into organs. The device was removed percutaneously. It was further reported that the detached strut retained in vertebra. The patient reportedly experienced back pain; however, the current status of the patient is unknown.

 
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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 Key10377562
MDR Text Key201991554
Report Number2020394-2020-05299
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062887
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received07/13/2020
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: 08/07/2020 Patient Sequence Number: 1
Treatment
AMBIEN, ATORVASTATIN CALCIUM, CELEBREX; COUMADIN, ELIQUIS, ADVAIR DISKUS; CYMBALTA, DALIRESP, DIAZEPAM, FERROUS SULFATE; OXYCODONE HCL, PERPHENAZINE, PROTONIX; REMERON, SINGULAIR, SPIRIVA; TIZANIDINE HCL, VENTOLIN HFA, VERAPAMIL HCL; VIMPAT
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