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

Catalog Number RF400J

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problem Pericardial Effusion (3271)

Event Date 01/12/2015

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10:d4 (expiry date: 05/2012).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.Approximately five years and seven months post filter deployment, it was alleged that the filter struts detached, perforated into organs and the detached struts migrated to right ventricle.The detached strut had migrated and found in right ventricle causing pericardial effusion.Reportedly, the device and the detached struts were removed after an unsuccessful removal procedure.; however, the current status of the patient is unknown.

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.Approximately five years and seven months post filter deployment, it was alleged that the filter struts detached, perforated into organs and the detached struts migrated to right ventricle.The detached strut had migrated and found in right ventricle causing pericardial effusion.Reportedly, the device and the detached struts were removed after an unsuccessful removal procedure.; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and 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.Approximately five years, six months and twenty-four days post filter deployment, the patient was diagnosed with pericardial effusion, probable cardiac tamponade.Preprocedural baseline fluoroscopy demonstrated a foreign body that appeared to be within the right ventricle.The location was confirmed in orthogonal views.The caliber and radial opacity of the linear objects appeared to be similar to the struts of the filter.Several attempts were made to snare the filter with the cook retrieval snare, a gooseneck snare, and an ensnare.The filter was snared several times but could not be collapsed as the fractured filter strut adjacent to the filter was sticking up beside the filter hook and prevented advancement of the sheath over the filter.Finally, the filter hook was pulled partially into the sheath, but the gooseneck snare detached.Repeat attempts were made to snare the filter within the sheath.Attempts were also made to grab the hook with endobronchial forceps, which did not have enough gripping power to pull the filter into the sheath.Eventually, the hook was again grabbed with the gooseneck snare and pulled into the sheath and out.The gooseneck snare was then used to remove the retained fractured strut from the inferior venacava.Attention was then turned to the strut embolized to the right ventricle.A 12fr x 30cm sheath was advanced over the wire into the right ventricle.Several attempts were made to grab the embolized strut with the gooseneck snare and ensnare which were unsuccessful.A 9 french reverse curve sheath was then advanced to the 12 french sheath and directed towards the anterior right ventricular wall in the location of the retained strut.The strut was then snared with a gooseneck snare and removed intact.Superior venacavogram showed no evidence for retained foreign body in the heart or lungs.G2x filter with two fractured struts, one of which embolized to the right ventricle, computed tomography angiography revealed the embolized strut to have perforated from the right ventricle into the pericardial space.Therefore, the investigation is confirmed for the reported perforation of caval wall, filter limb detachment and retrieval difficulty.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.H3 other text : device not returned.

• Brand Name: G2 EXPRESS 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 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16990432
• MDR Text Key: 315819090
• Report Number: 2020394-2023-00357
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

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 Catalogue Number: RF400J
• Device Lot Number: GFTD2437
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 08/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2009
• 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: SYNTHROID, ZOLOFT AND COUMADIN; SYNTHROID, ZOLOFT AND COUMADIN
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White