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

Catalog Number RF310F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Death (1802); Embolus (1830)

Event Type  Death  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records is not being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 have caused or contributed to the patient¿s death.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.

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: - 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.Date received by mfr.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 have caused or contributed to the patient¿s death.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.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive 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: 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: 06/2012), (manufacturing date: 06/2009), (patient).

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 have caused or contributed to the patient¿s death.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.At some time post filter deployment, it was alleged that the patient experienced pulmonary embolism and arterial embolus.Furthermore, it was alleged that the patient expired.The device has not been removed and there were no reported attempts made to retrieve the filter.

• 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: 6185742
• MDR Text Key: 62729933
• Report Number: 2020394-2016-01178
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K062887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• 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: GFTD1734
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2018
• 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; Other