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); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately eleven years and nine months post filter deployment, a computed tomography revealed the filter was tilted anteriorly to the right by 13 degrees relative to the long axis of the inferior vena cava and 22 degrees relative to the vertical axis.The upper tip of the filter was located near the anterior inferior vena cava wall and situated 3 cm below the confluence of the renal veins.The longer metallic struts of the filter were situated near the inferior vena cava bifurcation.A right posterior strut contacted the anterior superior margin of the vertebral body with focal sclerosis/osteophyte.A left anterior strut was located near the posterior wall of the right common iliac artery.Several of the metallic struts projected outside of the inferior vena cava wall by up to 1 cm in length and 3 to 4 mm in the transverse plane.The filter appeared to be tilted and a posterior strut may be embedded in the anterior margin of vertebra.Anterior strut contacted the posterior wall of the right common iliac artery.Tilt of the filter with protrusion of the legs into the iliac artery and spine was noted.The location of the struts, one of which was touched the iliac artery but does not appeared to penetrate the lumen.There was also a strut protruded toward the spine.The patient had experienced back pain.Eventually five months later the patient presented with abdominal pain.Subsequently filter retrieval was performed.A 6-french sheath was passed initially and attempted to snare the top of the filter; however, it was stuck to the side of the cava and could not be engaged.Then used a sos omni catheter and a glidewire and flipped through the interstices.Once looped through the filter, snared the end of the wire and controlled both ends of the wire and advanced the sheath downward release the filter.It did not fully enter the sheath.It was brought up and retrieved with the feet extending slightly through the end of the sheath.The filter gross examination revealed an aggregate of pink and red soft tissue attached to the filter with 12 prongs.Therefore, the investigation is confirmed for the perforation of the ivc, filter tilt and retrieval difficulties.However, the investigation is inconclusive for the filter limb detachment.Based on the available information, the definitive root cause is unknown.Labeling review: the current instructions for use states: warnings: filter removal: use only the bard recovery cone removal system (packaged separately) to retrieve the filter.Use of other removal devices has resulted in recurrent pulmonary embolism.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.(device: 4001).

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/pulmonary embolism.At some time post filter deployment, it was alleged that filter struts detached and perforated into organs.The device was removed percutaneously.It was further reported that the detached strut retained in vertebra.The patient reportedly experienced back pain; however, the current status of the patient is unknown.

• 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: 10377562
• MDR Text Key: 201991554
• Report Number: 2020394-2020-05299
• 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
• Report Date: 08/07/2020

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: RF310F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/07/2020
• 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: AMBIEN, ATORVASTATIN CALCIUM, CELEBREX; COUMADIN, ELIQUIS, ADVAIR DISKUS; CYMBALTA, DALIRESP, DIAZEPAM, FERROUS SULFATE; OXYCODONE HCL, PERPHENAZINE, PROTONIX; REMERON, SINGULAIR, SPIRIVA; TIZANIDINE HCL, VENTOLIN HFA, VERAPAMIL HCL; VIMPAT
• Patient Outcome(s): Other
• Patient Age: 49 YR