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

Catalog Number RF400F

Device Problems Complete Blockage (1094); Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Extrusion (2934); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Pain (1994); Great Vessel Perforation (2152); Thrombosis/Thrombus (4440)

Event Date 11/11/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: as medical images were not provided, a review could not be performed.Conclusion: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged tilted filter and perforation of the ivc wall as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: - movement, migration or tilt of the filter are known complications of vena cava filters.- perforation or other acute or chronic damage of the ivc wall - filter tilt - filter malposition note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.The information provided by bard 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 bard.

Event Description

It was reported that approximately five years ten months post vena cava filter deployment, a ct scan demonstrated the filter was allegedly tilted and multiple filter limbs extended beyond the wall of the ivc.There were no reported attempts made to retrieve the filter.The current status of the patient was not provided.

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.Images were not provided.Medical records were provided and reviewed.Approximately after six years, the patient experienced back and abdominal pain.Ct abdomen / pelvis demonstrated upper portion of the filter was adjacent to the anterior right wall and extends slightly through the wall inferiorly, periumbilical fatty hernia, right ovarian questionable mass, fatty liver and possible intracortical right kidney mid portion cyst.Therefore, the investigation is confirmed for filter tilt and perforation of the ivc.Based upon the available information, the definitive root cause is unknown.Labeling review: the current instructions for use states: warnings: movement, migration or tilt of the filter are known complications of vena cava filters.Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.Potential complications: movement, migration or tilt of the filter are known complications of vena cava filters.Perforation or other acute or chronic damage of the ivc wall, filter tilt, and filter malposition.Precautions: position the retrieval hook 1 cm below the lowest renal vein.Venacavography must always be performed to confirm proper implant site.Radiographs without contrast, which do not clearly show the wall of the ivc, may be misleading.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: 10/2011).

Event Description

It was reported that approximately five years ten months post vena cava filter deployment, a ct scan demonstrated the filter was allegedly tilted and multiple filter limbs extended beyond the wall of the ivc.There were no reported attempts made to retrieve the filter.The current status of the patient was not provided.New information: 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 and embedded in wall of the ivc and feet extend slightly through the lower wall of the ivc.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.

Manufacturer Narrative

H10: 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.Medical records were provided and reviewed.Approximately, three months of post deployment, a computed tomography angiogram of chest was performed for shortness of breath.The study showed that negative for pulmonary embolism.Around, one year and eight months later, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that inferior vena cava filter was noted.Around eight months later, a computed tomography of pelvis was performed for abdominal pain.The study showed that inferior vena cava filter was noted.Around, four years later, a computed tomography of abdomen and pelvis was performed for back pain and abdominal pain.The study showed that inferior vena cava filter was tilted slightly.The upper portion of the filter was adjacent to the anterior right wall and extends slightly through the wall inferiorly.Around, three years and eight months later, a computed tomography of chest was performed for suspected pulmonary embolism.The study showed that negative for acute pulmonary embolism.After, two days, an inferior vena cavogram was performed for filter thrombosis.The study showed that thrombus was seen in the inferior vena cava filter.After, four days, bilateral lower extremity mechanical and iliac vein thrombectomy was performed for deep vein thrombosis.Intraoperative findings showed that thrombus was noted within the filter and just above the filter.The inferior vena cava filter as well as inferior vena cava immediately superior to the filter were also subjected to mechanical thrombectomy with catheter aspiration and angiojet rheolysis.Around, one month and two weeks later, an inferior vena cavogram was performed which showed filter embedded in right lateral inferior vena cava wall and nearly occluded with clot below the apex of the filter.The filter apex was adjacent to the patient¿s right inferior vena cava wall.Around, three weeks later, patient was planned for filter retrieval procedure for occluded inferior vena cava.Through the right jugular vein approach, an inferior vena cavogram was performed.The study showed that complete occlusion of the distal inferior vena cava at the level of the confluence of the common iliac veins.Multiple attempts were made to access the indwelling inferior vena cava filter.The tip was adherent to and positioned within the right vessel wall.Multiple retrieval techniques were attempted.Eventually a loop snare was placed under the adherence between apex of the filter in the vessel wall.Snare was able to dissect the apex of the filter from the vessel wall and the filter apex was captured with a snare device.A sheath was advanced over the filter to dissected from the wall removing in its entirety.Inferior vena cava or the previously positioned filter was located documented to be completely occluded.A successful stenting of inferior vena cava was performed.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) , retrieval difficulties and complete occlusion of the inferior vena cava (ivc).Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.However, the investigation is inconclusive for filter tilt as it was mentioned as "slightly tilted".Based upon the available information, the definitive root cause is unknown.Labeling review: the current instructions for use states: warnings: - movement, migration or tilt of the filter are known complications of vena cava filters.Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.Potential complications: - movement, migration or tilt of the filter are known complications of vena cava filters.- perforation or other acute or chronic damage of the ivc wall - filter tilt - filter malposition precautions: position the retrieval hook 1 cm below the lowest renal vein.Vena cavography must always be performed to confirm proper implant site.Radiographs without contrast, which do not clearly show the wall of the ivc, may be misleading.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: b2,b6,d4(expiry date: 10/2011),g3,h6(patient, 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.Approximately five years and ten months post vena cava filter deployment , a computed tomography scan demonstrated that the filter tilted and embedded in wall of the inferior vena cava and multiple filter limbs extend slightly through the lower 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 EXPRESS 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: 6662388
• MDR Text Key: 78283461
• Report Number: 2020394-2017-00698
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080668
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• 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: GFSI2351
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2008
• 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: ACETAMINOPHEN, TRIAMTERENE, IRON POLYSACCHARIDES; ACETAMINOPHEN, TRIAMTERENE, IRON POLYSACCHARIDES; CARBIDOPA-LEVODOPA, CHOLECALCIFEROL; CARBIDOPA-LEVODOPA, CHOLECALCIFEROL; CYCLOBENZAPRINE, METFORMIN, MULTIVITAMIN; CYCLOBENZAPRINE, METFORMIN, MULTIVITAMIN; HEPARIN, SINEMET, VITAMIN D, FLEXERIL, GLUCOPHAGE; HEPARIN, SINEMET, VITAMIN D, FLEXERIL, GLUCOPHAGE; INSULIN HUMAN REGULAR. POTASSIUM CHLORIDE; INSULIN HUMAN REGULAR. POTASSIUM CHLORIDE; LISINOPRIL, PAROXETINE, COUMADIN, ESOMEPRAZOLE; LISINOPRIL, PAROXETINE, COUMADIN, ESOMEPRAZOLE; OMEPRAZOLE; OMEPRAZOLE; PAROXETINE, AND TRIAMTERENE-HYDROCHLOROTHIAZIDE; PAROXETINE, AND TRIAMTERENE-HYDROCHLOROTHIAZIDE; PAXIL, DYAZIDE, DEXTROSE, HYDROCODONE, LORAZEPAM; PAXIL, DYAZIDE, DEXTROSE, HYDROCODONE, LORAZEPAM
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 149 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White