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

Catalog Number RF400F

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems Abdominal Pain (1685); Hematoma (1884)

Event Date 08/18/2015

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 09/2012).

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 the filter detached.The device was removed percutaneously.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 after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter detached.The device was removed percutaneously.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, three years and five months of post deployment, patient presented with the complaints of abdominal pain.Ultrasound abdomen study showed cholecystitis and cholelithiasis.Around, ten months and three weeks later, a magnetic resonance imaging of lumbar spine was performed for low back pain.The study showed that disc protrusion to the left at l5-s1 level causing minimal inferior neural foraminal narrowing.Around, one year and three weeks later, patient presented with the complaints of extensive leg swelling.Ultrasound doppler study revealed totally occlusive left popliteal, femoral and iliac veins.Vena cavogram was performed which showed occlusive deep vein thrombosis.A glide catheter was introduced into the vena cava and hand contrast injection was performed.There was no flow noted at that level, however above the inferior vena cava filter the cava was patent and there was good flow.One of the struts of the inferior vena cava filter also angled from the main struts.An ekos infusion catheter was placed into the iliocaval system and infused tissue plasminogen activator overnight.On the next day, an inferior vena cavogram was performed and ekos catheter was removed.An angiojet thrombectomy was performed of the popliteal, femoral and iliac system up to the inferior vena cava below the filter and around it.The clots were removed, and balloon angioplasty was performed.Around, three months later, a computed tomography of abdomen and pelvis was performed which showed chronic occlusion and scarring of the inferior vena cava at the level of filter with complete occlusion to the bifurcation of the veins.Around, two months later, patient with chronically embedded inferior vena cava filter complicates by penetration fracture and planned for filter retrieval procedure.Through the right common femoral vein approach, a right iliocaval venogram was performed which showed occluded infrarenal inferior vena cava to the level of the inferior vena cava filter.Spot abdominal images over the abdomen demonstrates a bard g2 filter with one arm fracture superiorly.Two residual fragments were confirmed in a stable extraluminal position.Through the right jugular vein approach, a sheath was advanced into the infrarenal inferior vena cava below the existing filter.Rigid forceps were then advanced to first dissect free embedded filter apex and subsequently engage the filter hook.A trilobed ensnare was used to engage the filter within the sheath.The filter was successfully retrieved.After removal, the filter was visually inspected and five arms and five 2/3 legs were intact.Successful placement of stent in the infrarenal inferior vena cava at the mid l3 level.After three days, a computed tomography of angiogram of chest was performed which showed no evidence of pulmonary embolism.Around, one week later, patient presented with the complaints of excessive sweating, generalized weakness and right flank pain.Complicated by inferior vena cava tear, retroperitoneal hematoma and prolonged stay at hospital.A computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that large right retroperitoneal hematoma that causes significant anterior displacement of right kidney was noted.Around, two months later, a computed tomography study was performed which showed instent thrombosis of inferior vena cava stent and migration of old extravascular filter fragment into the lumen.The retained fragment was successfully retrieved.Therefore, the investigation is confirmed for filter limb detachment, material deformation, perforation of the inferior vena cava (ivc), retrieval difficulties and occlusion of the inferior vena cava (ivc).Based upon the available information, the definitive root cause is unknown.Labeling review: the current instructions for use states: warning: -do not attempt to remove the g2 express filter if significant amount of thrombus are trapped within the filter or if the filter hook is embedded within the vena cava wall.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.H10: d4(expiry date: 09/2012), g3, h6(method).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.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, three years and five months of post deployment, patient presented with the complaints of abdominal pain.Ultrasound abdomen study showed cholecystitis and cholelithiasis.Around, ten months and three weeks later, a magnetic resonance imaging of lumbar spine was performed for low back pain.The study showed that disc protrusion to the left at l5-s1 level causing minimal inferior neural foraminal narrowing.Around, one year and three weeks later, patient presented with the complaints of extensive leg swelling.Ultrasound doppler study revealed totally occlusive left popliteal, femoral and iliac veins.Vena cavogram was performed which showed occlusive deep vein thrombosis.A glide catheter was introduced into the vena cava and hand contrast injection was performed.There was no flow noted at that level, however above the inferior vena cava filter the cava was patent and there was good flow.One of the struts of the inferior vena cava filter also angled from the main struts.An ekos infusion catheter was placed into the iliocaval system and infused tissue plasminogen activator overnight.On the next day, an inferior vena cavogram was performed and ekos catheter was removed.An angiojet thrombectomy was performed of the popliteal, femoral and iliac system up to the inferior vena cava below the filter and around it.The clots were removed, and balloon angioplasty was performed.Around, three months later, a computed tomography of abdomen and pelvis was performed which showed chronic occlusion and scarring of the inferior vena cava at the level of filter with complete occlusion to the bifurcation of the veins.Around, two months later, patient with chronically embedded inferior vena cava filter complicates by penetration fracture and planned for filter retrieval procedure.Through the right common femoral vein approach, a right iliocaval venogram was performed which showed occluded infrarenal inferior vena cava to the level of the inferior vena cava filter.Spot abdominal images over the abdomen demonstrates a bard g2 filter with one arm fracture superiorly.Two residual fragments were confirmed in a stable extraluminal position.Through the right jugular vein approach, a sheath was advanced into the infrarenal inferior vena cava below the existing filter.Rigid forceps were then advanced to first dissect free embedded filter apex and subsequently engage the filter hook.A trilobed ensnare was used to engage the filter within the sheath.The filter was successfully retrieved.After removal, the filter was visually inspected and five arms and five 2/3 legs were intact.Successful placement of stent in the infrarenal inferior vena cava at the mid l3 level.After three days, a computed tomography of angiogram of chest was performed which showed no evidence of pulmonary embolism.Around, one week later, patient presented with the complaints of excessive sweating, generalized weakness and right flank pain.Complicated by inferior vena cava tear, retroperitoneal hematoma and prolonged stay at hospital.A computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that large right retroperitoneal hematoma that causes significant anterior displacement of right kidney was noted.Around, two months later, a computed tomography study was performed which showed instent thrombosis of inferior vena cava stent and migration of old extravascular filter fragment into the lumen.The retained fragment was successfully retrieved.Therefore, the investigation is confirmed for filter limb detachment, material deformation, perforation of the inferior vena cava (ivc), retrieval difficulties and occlusion of the inferior vena cava (ivc).However, the investigation is inconclusive for filter tilt.Based upon the available information, the definitive root cause is unknown.Labeling review: the current instructions for use states: warning: -do not attempt to remove the g2 express filter if significant amount of thrombus are trapped within the filter or if the filter hook is embedded within the vena cava wall.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.H10: b5, d4 (expiry date: 09/2012), g3, h6 (device).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.

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 the filter tilted, detached, perforated, materially deformed and occluded.The device was removed percutaneously.The patient reportedly experienced with abdominal pain and was diagnosed with retroperitoneal hematoma; however, the current status of the patient is unknown.

• Brand Name: G2 X 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: 13124820
• MDR Text Key: 283089600
• Report Number: 2020394-2021-80840
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082305
• 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,Followup
• Report Date: 04/04/2022

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: RF400F
• Device Lot Number: GFTH3217
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/31/2021
• Supplement Dates Manufacturer Received: 01/04/2022; 03/30/2022
• Supplement Dates FDA Received: 01/31/2022; 04/04/2022
• 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: EPINEPHRINE, AMIODARONE, NEOSYNEPHRINE; EPINEPHRINE, AMIODARONE, NEOSYNEPHRINE; EPINEPHRINE, AMIODARONE, NEOSYNEPHRINE; VERSED, SODIUM BICARBONATE, ZOFRAN; VERSED, SODIUM BICARBONATE, ZOFRAN; VERSED, SODIUM BICARBONATE, ZOFRAN
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Race: White