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

Catalog Number RF310F

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Pulmonary Embolism (1498); Death (1802); Blood Loss (2597)

Event Date 04/16/2016

Event Type  Death  

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.Images and medical records were not provided.There was no specific deficiency alleged.The investigation is inconclusive.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: potential complications: possible complications include, but are not limited to, the following: movement, migration or tilt of the filter are known complications of vena cava filters.Migration of filters to the heart or lungs has been reported.There have also been reports of caudal migration of the filter.Migration may be caused by placement in ivcs with diameters exceeding the appropriate labeled dimensions specified in this ifu.Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens; 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; 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; deep vein thrombosis; caval thrombosis/occlusion; extravasation of contrast material at time of venacavogram; air embolism; hematoma or nerve injury at the puncture site or subsequent retrieval site; hemorrhage; restriction of blood flow; occlusion of small vessels; distal embolization; infection; intimal tear; stenosis at implant site; failure of filter expansion/incomplete expansion; insertion site thrombosis; filter malposition; vessel injury; arteriovenous fistula; back or abdominal pain; filter tilt; hemothorax; organ injury; phlegmasia cerulea dolens; pneumothorax; postphlebitic syndrome; stroke; thrombophlebitis; venous ulceration; blood loss; guidewire entrapment; pain.All of the above complications may be associated with serious adverse events such as medical intervention and/or death.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 some time post filter deployment (date not provided) the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death, the cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.

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.This is the only event reported to date for this lot number and failure mode.Medical record review: an inferior vena cava (ivc) filter was deployed via the left femoral vein on (b)(6) 2008 for venous thromboembolic disease, and contraindication to anticoagulation due to significant epistaxis followed by hematuria and suspected gastrointestinal bleed.A vena cavogram performed during ivc filter deployment revealed no intracaval thrombus so the diameter of the vena cava was adequate for ivc filter placement and the insertions of the renal veins were noted.Six days post ivc deployment, the patient was discharged without anticoagulation.Approximately seven years and five months post ivc filter deployment a lower venous examination was performed for asymptomatic obstruction and shortness of breath and demonstrated chronic thrombotic scarring within the right common femoral and femoral veins and no evidence of deep vein thrombosis within the lower extremity.The next month the patient presented with pulmonary embolisms with hemoptysis.Ct chest imaging demonstrated partially occlusive pulmonary embolism involving the right lower segmental pulmonary artery, which; stated as an acute or subacute embolic disease and a significant endobronchial opacification within the right lower lobe bronchi possibly from mucous plugging or endobronchial secretions.In addition, the ct demonstrated a mild bilateral lobe atelectasis and possible patch right lower pneumonia.Patient was started on heparin and transferred for a high level of care.Abdominal x-ray performed for ivcf positioning demonstrated the vena cava filter in place with the cephalad end of the ivc filter at the level of the inferior endplate of l2.The ivc filter may not have been completely expanded.Subsequent ct of the abdomen & pelvis again demonstrated the vena cava filter in place but did not appear to be completely expanded.No thrombus was identified within the inferior vena cava above the level of the filter.Patient passed away same day.The certificate of death noted cause of death to be chronic obstructive pulmonary disease and acute pulmonary embolus.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Approximately seven years and six months post deployment, the patient presented with pulmonary embolisms with hemoptysis.Ct chest imaging demonstrated partially occlusive pulmonary embolism involving the right lower segmental pulmonary artery.Approximately seven years and six months post deployment, abdominal x-ray performed for ivcf positioning demonstrated the ivc filter may not have been completely expanded.The next day, a ct of the abdomen & pelvis was performed for multiple pulmonary embolisms which again demonstrated the vena cava filter in place but did not appear to be completely expanded.The patient passed away that day.The certificate of death noted cause of death to be chronic obstructive pulmonary disease and acute pulmonary embolus.Therefore, it can be confirmed that the patient experienced pe post deployment; however, the relationship to the filter is unknown.Additionally, the investigation is confirmed for failure to expand.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.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 some time post filter deployment (date not provided) the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death, the cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.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.Approximately seven years five months post filter deployment, it was alleged that the patient was diagnosed with pulmonary embolism.Furthermore, the patient was transported to a hospital where the patient experienced spontaneous bleeding.Additionally, the ivc filter did not completely expand.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient expired some time post vena cava filter deployment (date 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6268054
• MDR Text Key: 65452682
• Report Number: 2020394-2016-01294
• 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: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• 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: GFSE2803
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2018
• 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
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 75