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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 Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/17/2006
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: the device was not returned for evaluation. The medical records included images. The image review was documented in the medical records. Medical records were provided and reviewed. Approximately eight months later, the patient presented for filter removal, the right internal jugular vein was percutaneously accessed. Over the amplatz wire, advanced a pigtail catheter into the inferior vena cava inferior to the filter. Through this pigtail catheter, an inferior vena cavogram was performed. The filter was just below the level of the renal veins. The filter was tilted. A 10 french dilator/introducer was advanced. The cone device was advanced to just above the filter. Never get the tip of the filter to engage. One of the struts flipped up into the left renal vein. Attempts were made through the sheath utilizing several different wires including an amplatz and an 0. 035 glidewire. Able to steer these wires to some degree through a 5 french bernstein catheter. Attempted to engage the filter into the nose cone multiple times and it just never get around the tip of the vena cava. One fluoroscopic image was obtained, and it looked like the tip of the filter may have actually been embedded in the inferior vena cava, so the patient may actually have some scarring on the tip of the filter in the inferior vena cava. Inserted a small snare device, but never able to get the snare around the tip of the filter. Filter removal procedure was aborted. After one year and five months later, computed tomography of abdomen revealed the filter was not significantly tilted relative to the long axis of the inferior vena cava filter. The superior tip of the filter was at the level of the inferior vena cava and bilateral renal vein confluences. Posteriorly on the left, a filter strut perforates 11 mm beyond the inferior vena cava and abuts the anterior aspect of the spine. Laterally on the left, a filter strut perforates 10 mm beyond the inferior vena cava and abuts or perforates the aorta. Laterally on the left, a filter strut perforates 14 mm beyond the inferior vena cava and abuts or perforates the aorta and an adjacent small bowel loop. Anteriorly on the left, there are equivocal findings for a filter strut perforation of the inferior vena cava 5 mm and abut or perforate a small bowel loop. No definitive fracture of the inferior vena cava filter was seen. Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava, filter tilt, material deformation, filter migration and the retrieval difficulties. However, the investigation is inconclusive for alleged and filter detachment. Based upon the available information, the definitive root cause is unknown. Labeling review: 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. Expiry date: 11/2008.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident. At some time post filter deployment, it was alleged that the entire filter migrated to heart, tilted, struts detached and perforated in to the organ. The device has not been removed after an attempted but unsuccessful percutaneous removal procedure. The detached struts retained in body and has not been removed after an attempted but unsuccessful percutaneous removal procedure. 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 Key11751385
MDR Text Key250943616
Report Number2020394-2021-80403
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 consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF310F
Device Lot NumberGFPJ1927
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2005
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: 04/30/2021 Patient Sequence Number: 1
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