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

Catalog Number RF310F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685)

Event Date 04/06/2010

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history record review could not be performed as the lot number is unknown.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 five months post deployment, it was discovered that the inferior vena cava filter was protruding through the vena cava.The omni flush catheter was removed over the amplatz wire.Progressive dilatation of the tract was performed with eventual placement of the cook gunther-tulip filter removal sheath.The wire and inner dilator were then removed.The included snare was advanced through the sheath.Considerable time spent attempting to grasp the hook on the filter.In addition, a 20 mm amplatz gooseneck snare and a 18-30 mm ensnare were also used.All 3 devices failed to be able to grasp the hook.Further imaging and a review of the computed tomography scan suggested that the hook was adherent to the caval wall.At this point it was decided to attempt to free of the hulka and colon from the wall.The right internal jugular vein was re-accessed utilizing a new micro puncture set.An exchange length stiff glidewire was advanced through the introducer and into the infrarenal inferior vena cava.The introducer was replaced with a 5 french vascular sheath.The omni flush catheter was reinserted.Utilizing the omni flush catheter and glidewire, the filter cone was encircled.The glidewire was then snared via the other, initial internal jugular access.Through and through glidewire access was established.The ends of the glidewire then pulled in an attempt to free up the hook.This was unsuccessful and resulted in inversion of 4 of the filter legs.Inferior vena cavography confirmed the findings.The whole filter has more of a horizontal orientation and the cone appears adherent.The 2 legs remain perforated to a similar degree.The top of the filter was once again encircled and through and through access was established.Pressure was again applied which failed to release the cone but resulted in additional inversion of 5 more struts.Only 3 struts remained oriented inferiorly.Note was made that one of the perforated struts was now entirely intracaval in location.The other perforated strut which extended anteriorly had been pulled back into the cava a significant degree.One final attempt made from the right common femoral vein approach utilizing the same technique.The vein was accessed twice with placement of 5 and 6 french vascular sheaths.The same through and through technique was utilized.A new exchange length stiff glidewire was needed.Once again the cone was encircled.The pressure was applied which again failed to release the cone from the filter wall around two years and eight months later, x ray of lumbar sacral spine was performed and an inferior vena cava filter appeared to be rotated.Around six months later, x ray of lumbar sacral spine redemonstrated a rotated/ malpositioned inferior vena cava filter at the l2 and l3 levels, likely related to removal procedure failure.Around two years later, the patient with inferior vena cava filter had pulmonary embolism and back pain.The inferior vena cava filter has changed in orientation such that it is oriented in an ap oblique dimension rather than a craniocaudal fashion.Around one month later, deep vein thrombosis and recent pulmonary embolism.Around one year and eight months later, x ray showed inferior vena cava filter in horizontal position.Around four months later, x ray showed inferior vena cava filter at the level of l2/3, appeared markedly tilted, with splaying of the anchoring tines.Around eleven months later, x-ray of the abdomen showed a rotated malpositioned inferior vena cava filter.An inferior vena cava filter was seen with its tip pointing inferolaterally to the right.Around ten days later, computed tomography revealed an inferior vena cava filter had migrated cranially and had near horizontal position with limbs extending over the midline to the aorta.Around two days later, stable displaced inferior vena cava filter with its tip pointing right side and inferiorly was noted.Around one year later, computed tomography of abdomen showed that there was prominent tilt of the inferior vena cava filter with the hook of the inferior vena cava filter angled approximately 90 degrees from a long axis and abutting the anterior lateral wall of the inferior vena cava wall.Superior most strut of the filter was located below the confluence of the renal veins, but rotatory migration may have occurred.Two struts extend beyond the wall of the inferior vena cava.One strut extended approximately 0.5 cm beyond the wall of the inferior vena cava.Another strut extended approximately 1.3 cm beyond the wall of the inferior vena cava and abutted the aorta.Inferior vena cava filter in place with a rotatory tilt of the hook located approximately 90 degrees from the long axis of the inferior vena cava.Rotatory migration of the inferior vena cava filter with the superior most right still below the confluence of the renal veins.Two struts of the inferior vena cava filter extended beyond the wall of the inferior vena cava.One strut extended approximately 1.3 cm beyond the wall of the inferior vena cava and abutting the aorta.Therefore, the investigation is confirmed for filter tilt, perforation of inferior vena cava, material deformation and retrieval difficulties.Additionally, it can be confirmed that the patient experienced pe post deployment.However, the relationship to the filter is unknown.Per medical records, multiple attempts were made to engage the apex of the filter but were unsuccessful due to filter tilt, perforation of inferior vena cava and material deformation.This could have contributed to the retrieval difficulties.However, 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.

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 and stomach cancer surgery.At some time post filter deployment, it was alleged that the filter tilted and embedded in wall of the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.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: 13281214
• MDR Text Key: 284019681
• Report Number: 2020394-2022-90034
• 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: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/18/2022
• 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 Sequence Number: 1
• Treatment: CLARITIN; HYDROCHLOROTHIAZIDE, NORVASC, NORCO, XANAX
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Race: Black Or African American