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

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.

• Brand Name: G2 FILTER SYSTEM - FEMORAL
• Type of Device: VENA 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 Key: 11751385
• MDR Text Key: 250943616
• Report Number: 2020394-2021-80403
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF310F
• Device Lot Number: GFPJ1927
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR