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

Catalog Number RF310F

Device Problems Detachment of Device or Device Component (2907); Extrusion (2934)

Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Great Vessel Perforation (2152)

Event Date 01/02/2011

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.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: the patient presented with pulmonary emboli, therefore, vena cava filter placement was indicated.Using standard micropuncture technique, access was gained to the right common femoral vein.A venacavagram demonstrated no evidence of acute thrombus.Due to concern of possible future pregnancy, the decision was made to place the filter in a suprarenal position.The filter was successfully deployed at the t10 vertebral body level.Manual compression was applied at the access site for hemostasis.The patient tolerated the procedure well without immediate complications.Approximately three years three months post filter deployment, a ct of the chest demonstrated small volume pulmonary embolus.Approximately five years three months post filter deployment, a ct of the chest demonstrated two detached filter limbs in the heart, unchanged in configuration from a previous examination: one within the apex of the right ventricle, and one in the right pulmonary artery.There was no indication for removal of the two detached limbs at that time.Approximately seven years post filter deployment, diagnostic imaging demonstrated a detached limb in the heart and lung and filter limbs extending beyond the confines of the ivc wall.The findings were considered to be asymptomatic at that time.Approximately eight years post filter deployment, the patient presented with a marked increase in ongoing chest pain.A review of previous examinations demonstrated the two detached limbs in the heart to be stable and unchanged in configuration.The physician felt that the pain could be attributed to the detached limbs as there was no other source for the pain.The patient was made aware of surgical options for removal of the detached limbs and would return for follow up in three months.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was not returned.Images not provided.Medical records were provided and reviewed.Vena cava filter was successfully deployed.Three years and three months post filter deployment, ct scan identified small volume pulmonary embolus.Five years and three months post filter deployment, a ct scan demonstrated two detached filter limbs, one in the right ventricle and one in the right pulmonary artery.Seven years post filter deployment, imaging demonstrated the unchanged detached filter limbs and the strut of the filter to be extending beyond the ivc wall.Based on the medical records, the investigation can be confirmed for perforation of the ivc wall and detachment of filter limbs.Pe after filter implantation can also be confirmed from the provided medical records.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications/precautions: - movement, migration or tilt of the filter are known complications of vena cava filter - 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.-the safety and effectives of this device has not been established for pregnancy, nor in the suprarenal placement position.-procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.- perforation or other acute or chronic damage of the ivc wall.-acute or recurrent pulmonary embolism.This has been reported despite filter usage.It is not known if thrombi passed through the filter, or originated from superior or collateral vessels.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 a vena cava filter was deployed successfully, the reason for the filter deployment was not provided.No alleged deficiency with the device was reported.No other information regarding this event was provided.The patient status at this time is unknown.New information received: medical records were received and reviewed.Approximately three years three months post vena cava filter deployment, a ct scan demonstrated small volume pulmonary embolus.Approximately four years post filter deployment, a ct scan demonstrated two detached filter limbs: one within the right ventricle and one within the right pulmonary artery.Approximately seven years post filter deployment, imaging demonstrated filter limbs extending beyond the confines of the ivc wall.Approximately eight years post filter deployment, the patient presented with ongoing chest pain that the physician felt could be attributed to the two detached limbs.No additional information surrounding this event was provided in the medical records received.

• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6177141
• MDR Text Key: 62452557
• Report Number: 2020394-2016-01176
• 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: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2016
• 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: GEODON, ULTRAM, COUMADIN, SENNA DOCUSATE; NORVASC, RANITIDINE, LAMICTAL, PRAZOSIN
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 26 YR
• Patient Weight: 108