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); Extrusion (2934)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Great Vessel Perforation (2152); Cardiac Perforation (2513); Device Embedded In Tissue or Plaque (3165)

Event Date 05/25/2007

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged perforation of the ivc, filter limb detachment, removal difficulties, and tilting of the filter 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: filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.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.(b)(4).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 some time post filter deployment, it was alleged that the filter tilted, perforated the ivc, and a filter limb detached and embolized to the right ventricle.An open abdominal procedure was performed to retrieve the filter; however, it is unknown if the retrieval attempt was successful.A detached filter limb remains in the patient's right ventricle.The status of the patient was not provided.

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 sixteen days post deployment, computed tomography angio chest revealed intraluminal defect in an inferior branch of the right pulmonary artery consistent with a small pulmonary embolus.Around nine years and five months later, a computed tomography abdomen and pelvis revealed that the filter¿s medial struts had fractured and migrated into the right ventricle.Around three months later, a computed tomography chest revealed there was a linear metallic density at the right ventricular apex likely representing the dislodged filter strut.The tip of the strut was noted to extend to the right ventricular wall.Filter in an infra renal position and 11 filter struts were noted.The next day, foreign body object removal was planned.Attempts were made to snare it using a 10mm micro snare but was unsuccessful.Around two days later, foreign body object removal was planned again.Attempts were made to snare it using a 10mm micro snare but was unsuccessful.Around three days later, under fluoroscopic guidance, the location of the foreign body was identified in the right ventricle anterior wall near the apex.Around one month later, the patient was noted to have a fractured filter strut having migrated to the right ventricle where it was imbedded.Some extraluminal displacement of some of the filter legs.Around four months later, a computed tomography abdomen and pelvis revealed there was filter strut seen in the right ventricle which was stable.Around one year and six months later, a computed tomography angio chest revealed unchanged thin metallic strut embedded at apex right lateral ventricle and adjacent intraventricular septum.Therefore, the investigation is confirmed for filter limb detachment, retrieval difficulties and perforation of ivc.However, the investigation is inconclusive for filter tilt.Additionally, it can be confirmed that the patient experienced pe post deployment.However, the relationship to the filter is unknown.Based upon 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.

Event Description

It was reported through the litigation process that some time post filter deployment, it was alleged that the filter tilted, perforated the ivc, and a filter limb detached and embolized to the right ventricle.An open abdominal procedure was performed to retrieve the filter; however, it is unknown if the retrieval attempt was successful.A detached filter limb remains in the patient's right ventricle.The status of the patient was not provided.

• 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: 7299093
• MDR Text Key: 101025542
• Report Number: 2020394-2018-00157
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• 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: GFQI0210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2022
• 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: ALBUTEROL SULFATE, ENALAPRIL, GABAPENTIN; CHOLECALCIFEROL, WARFARIN AND MULTIVITAMIN; OXYCONTIN, PERCOCET, PROAIR HFA, TRIAMTERENE
• Patient Outcome(s): Life Threatening; Required Intervention; Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 136 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White