MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2X FILTER SYSTEM - JUGULAR; VENA CAVA FILTER

Catalog Number RF400J

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient-Device Incompatibility (2682); Extrusion (2934); Migration (4003)

Patient Problems Death (1802); Great Vessel Perforation (2152); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2012

Event Type  Death  

Manufacturer Narrative

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.This is the only event reported to date for this lot number and failure mode.Medical record review: vena cava filter was placed at l2 in a patient with contraindication to anticoagulation and deep vein thrombosis.Fluoroscopy showed the filter placed more lateral than typically seen.Approximately five and a half years post filter deployment, ct renal stone showed vena cava filter unchanged from ct three years earlier with multiple tines extending outside of the wall of the ivc.One month later, ct abdomen/pelvis showed malpositioned suprarenal ivc filter extending into the right renal vein.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Based on the medical records, the investigation can be confirmed for filter migration, perforation of the ivc, and tilted 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 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 migrated and multiple filter limbs perforated the wall of the ivc.The patient allegedly expired; however, the cause of the patient¿s death was not provided.

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.Bard g2x filter was deployed at the top of the filter at the level of second lumbar vertebra the patient with history of deep vein thrombosis and pulmonary embolism and accessed through the internal jugular vein.Fluoroscopy performed on the same day revealed that the filter was seen to the right of what appear to be upper lumbar vertebral bodies.The filter was somewhat more lateral than was typically seen.Approximately, five years and four months of post deployment, a computed tomography (ct) renal stone was performed, and it revealed that the filter unchanged in appearance, with multiple tines extending outside the wall of the inferior vena cava.Around, one year and seven months later, a computed tomography (ct) chest with contrast was performed and it revealed there was a suprarenal inferior vena cava filter with tines penetrating the inferior vena cava towards the right renal sinus, renal artery and vein.Around, eleven months later, the patient reportedly expired and death certificate was provided.The cause of death was acute or chronic respiratory failure and other causes of death was given as coronary artery disease, deep vein thrombosis and sleep apnea.Therefore, the investigation is confirmed for filter tilt, filter migration and perforation 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: 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.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: g1, h6(device, method, conclusion).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 migrated and multiple filter limbs perforated the wall of the inferior vena cava.The patient allegedly expired; however, the cause of the patient¿s death was not provided.

• Brand Name: G2X FILTER SYSTEM - JUGULAR
• 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: 7402982
• MDR Text Key: 104569401
• Report Number: 2020394-2018-00346
• 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
• 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 Expiration Date: 04/30/2012
• Device Catalogue Number: RF400J
• Device Lot Number: GFTC2571
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 04/03/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2009
• 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: COUMADIN, METOPROLOL, LASIX, METFORMIN; COUMADIN, METOPROLOL, LASIX, METFORMIN; SPIRIVA, VICODIN, ASPIRIN, PRAVACHOL; SPIRIVA, VICODIN, ASPIRIN, PRAVACHOL; VALIUM, SPIRONOLACTONE, LISINOPRIL, CELEXA; VALIUM, SPIRONOLACTONE, LISINOPRIL, CELEXA; COUMADIN, METOPROLOL, LASIX, METFORMIN; SPIRIVA, VICODIN, ASPIRIN, PRAVACHOL; VALIUM, SPIRONOLACTONE, LISINOPRIL, CELEXA
• Patient Outcome(s): Death
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Race: White