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); Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problem Pain (1994)

Event Date 11/24/2012

Event Type  Injury  

Manufacturer Narrative

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.An unknown inferior vena cava filter was deployed in the infra renal vein location without difficulty, for a patient with morbid obesity and in conjunction prior to bariatric surgery.Approximately six years and three months of post deployment, the patient presented with back pain.On the same day, a computed tomography (ct) abdomen and pelvis showed that there was a vena caval filter and the filter had migrated cephalad, when compared with the examination two years ago.In addition, 1 of the limbs of the filter was not directed cephalad and appeared to have been broken from the rest of the device.There was a second limb of the filter, which was also discontinuous and had broken from the rest of the device.The uppermost aspect of the cephalad directed limb lay at the level of the confluence of the right renal vein and inferior vena cava but did not projected above that level.After 3 days, the patient reported with migrated greenfield filter.After one week and two days, the patient presented with right lower quadrant abdominal pain.On the same day, a computed tomography (ct) scan demonstrated protruded arms of the inferior vena cava filter.There was limb fracture and perforation of the vena cava from the g2 inferior vena cava filter.The filter was also malpositioned.After two weeks and one day, an attempt was made to retrieve the fractured inferior vena cava filter from the patient¿s body.Multiple fractured limbs were noted in the imaging studies.Jugular vein was accessed with a large bore needle.Under fluoroscopic guidance, an extraction sheath was inserted.The g2 cone was used.Multiple attempts to capture the filter were unsuccessful.A snare was placed and multiple attempts to grab the tip of the cone were unsuccessful.The snare was pushed beyond the filter and a wire was inserted.This was then snared and pulled back, that grabbed the majority of the filter.Multiple attempts were made to pull the filter into the sheath; this was unsuccessful.The cone was again tried without success.After multiple attempts manipulated to remove the catheter tip and engage it in the cone, the procedure was aborted.After one month and one day, a computed tomography (ct) scan demonstrated that the filter was quite fragmented.The head of the filter was buried in the wall of the vena cava.One fragment of the filter detached and had worked its way along the lateral margin of the spine.Other legs of the filter were deeply penetrated into perivascular soft tissues in front of the spine, behind the aorta and between the aorta and cava.A fully detached fragment had come free of the filter and had lodged in the hepatic veins.After one week and one day, a computed tomography (ct) abdomen showed that the filter remained in stable position in the infra renal inferior vena cava.One of the metal legs of the filter was in an inappropriate position, that extended along the right lateral side of the l3 vertebral body.An additional limb of the filter extended medially under the abdominal aorta just above the bifurcation, which was also stable.After three weeks and six days, an ultrasound duplex upper extremity venous right showed no evidence of deep or superficial venous thrombosis in the right upper extremity.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter migration, filter limb detachment, filter malposition and retrieval difficulties.However, the investigation is inconclusive for material deformation.Based on 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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure.At some time post filter deployment, it was alleged that the filter migrated to heart, struts detached and perforated.The device has not been removed after an attempted but unsuccessful removal procedure.It was further reported that the detached struts retained in spine, vena cava and hepatic veins.The current status of the patient is unknown.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure.At some time post filter deployment, it was alleged that the filter migrated to heart, struts detached and perforated.The device has not been removed after an attempted but unsuccessful removal procedure.It was further reported that the detached struts retained in spine, vena cava and hepatic veins.The patient reportedly experienced back pain and right lower quadrant abdominal pain; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: 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.After one-week later post filter deployment, a computed tomography of abdomen was performed for diffuse abdominal pain.The study showed that inferior vena cava filter was noted.A computed tomography of chest was performed which showed negative for pulmonary embolism.After six months, a computed tomography of abdomen was performed for right sided flank pain.The study showed that inferior vena cava filter was noted in place.After three weeks, a computed tomography angiogram of abdomen was performed which showed inferior vena cava filter was deployed below the level of renal veins.After three years and four months, a computed tomography of abdomen and pelvis was performed for right upper quadrant pain.The study showed that inferior vena cava filter was noted in place.After two years and three months, patient presented with the complaints of back pain.A computed tomography of abdomen and pelvis was performed which showed inferior vena cava filter demonstrated and the filter was migrated cephalad.One of the limbs of the filter was not directed cephalad and appears to have been broken from the rest of the device.There was a second limb of the filter which was also discontinues and has broken from the rest of the device.The uppermost aspect of the cephalad directed limb lies at the level of the confluence of the right renal vein and inferior vena cava but does not project above this level.After one month, patient underwent attempted extraction of fractured filter.Through the right jugular vein approach, a g2 cone was inserted.Multiple attempts to capture the filter were unsuccessful.A snare was placed and multiple attempts to grab the tip of the cone were unsuccessful.The snare was pushed beyond the filter and pulled back, grabbing the majority of the filter.Multiple attempts were made to pull the filter into the sheath.This was unsuccessful.The cone was again tried without success.After multiple attempts to remove manipulate the catheter tip and engage it in the cone, the procedure was aborted.After one month, patient presented for an outpatient clinical for the symptoms that potentially to be due to the filter.An attempt was made to remove the filter but unsuccessful.A computed tomography scan was performed which showed that the filter was quite fragmented.The head of the filter was buried in the wall of the vena cava.One fragment of the filter has become detached and has worked its way along the lateral margin of the spine.Other legs of the filter are deeply penetrated into perivascular soft tissues in front of the spine, behind the aorta and between the aorta and cava.A fully detached fragment has come free of the filter and has lodged in the hepatic veins.After one-week, a computed tomography of abdomen was performed for fracture filter.The study showed that filter remains in stable position in the infrarenal inferior vena cava.One of the metal legs of the filter in an inappropriate positioned extending along the right lateral side of the l3 vertebral body.An additional limb of the filter extends medially under the abdominal aorta just above the bifurcation which was also stable.After four years and six months, a computed tomography angiogram of chest was performed for upper back pain.The study showed that negative for pulmonary embolism.After two years and three months, patient presented with the complaints of chest pain, back pain and shortness of breath.A computed tomography angiogram of chest was performed which showed negative for pulmonary embolism.After five months, a computed tomography of abdomen and pelvis was performed which showed inferior vena cava filter was noted.Its proximal tip was located 3.0 cm below the right renal vein, at the l3 level.There was anterior tilt of the filter in relation to the axis of the inferior vena cava measuring approximately 20 degrees.There was lateral tilt to the right measuring approximately 12 degrees.There was perforation of the medial wall of the inferior vena cava with one of the legs extending approximately 1 cm medially.Also, the legs were detached and perforated the posterior wall of the vein.It was located along the right side of l3 vertebral body extending 2.5 cm posteriorly.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava, filter migration, material deformation, filter limb detachment, filter tilt and retrieval difficulties.Based on 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.H11: section a through f - the information provided by bd 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 bd.

• 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: 12179204
• MDR Text Key: 261900794
• Report Number: 2020394-2021-80569
• 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,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2022
• 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: OMEPRAZOLE, XANAX, BUPROPION, PROZAC AND PREVACID; OMEPRAZOLE, XANAX, BUPROPION, PROZAC AND PREVACID; OMEPRAZOLE, XANAX, BUPROPION, PROZAC AND PREVACID
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White