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

Catalog Number RF310F

Device Problems Complete Blockage (1094); Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problem Abdominal Pain (1685)

Event Date 03/27/2014

Event Type  Injury  

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient due to deep vein thrombosis prophylaxis after patient experienced quadriparesis.At some time post filter deployment, it was alleged that the patient experienced inferior vena cava filter perforation, chronic thrombosis, and stenosis post filter implant.Furthermore, the patient alleged the device was unable to be retrieved.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately four years and four months later, computerized tomography-abdomen showed an inferior vena cava filter in place with apparent migration of one of its legs into the adjacent soft tissues medially.After, three days, patient presented with the complaints of acute abdominal pain.On the next day, an inferior vena cavogram was performed for thrombosed inferior vena cava filter.The study showed that displaced filter with possible extrusion to the soft tissues.Around, one month later, an inferior vena cavogram was performed which showed total occlusion at the level of the inferior vena cava filter which appears to be located in the right common iliac vein.There also appears to be some extrusion of the filter across the wall of the vein that shows malposition of the filter.There was significant collateralization and there was no flow after the filter.An inferior vena cava filter seen in place, one of its legs appeared to have migrated into the adjacent soft tissues medially.After four days, the patient underwent inferior vena cava filter removal.Access was gained via right femoral vein by the modified seldinger technique, and a vascular sheath was placed.After that, performed a venogram using contrast dye in multiple views.After that, they reviewed the diagnostic images and decided the patient needed to have an intervention at the level of the inferior vena cava filter.Attempted but failed intervention of the right common iliac vein with displaced inferior vena cava filter in the right iliac vein with possible extension into the medial soft tissue.Pulling the sheath and achieving hemostasis in the cardiac cath lab.An angiography was showed that there was total occlusion at the level of the inferior vena cava filter which appears to be in the right common iliac vein.There also appears to be some extrusion of filter across the wall of the vein.There was significant collateralization, and there was no flow after the filter.After one week, a venogram revealed some thrombosis of inferior vena cava filter.After two years and nine months, computerized tomography abdomen /pelvis with contrast showed an inferior vena cava filter likely a bard g2 which was positive for perforation and negative for tilt.Posterior strut abuts right common iliac artery (rcia) (8 mm) and posterior struts abut sup l5 (7 and 11 mm).The legs of the filter penetrated through the wall of the inferior vena cava into the pericaval/mesenteric fat.The filter was present in the distal inferior vena cava.At the level of the filter the inferior vena cava was very stenotic.Therefore, the investigation is confirmed for the alleged filter occlusion, perforation of the inferior vena cava, filter tilt and the retrieval difficulties.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.

• 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: 14183952
• MDR Text Key: 289861919
• Report Number: 2020394-2022-90155
• 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: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• 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
• Date Manufacturer Received: 04/06/2022
• 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, BUSPAR, CELEXA; CLINDAMYCIN, LEVOFLOXACIN, RIVAROXABAN; COUMADIN, DITROPAN, FLEXERIL, LASIX; NEURONTIN, NORCO, XANAX, ZOFRAN, NAPROXEN; POTASSIUM CHLORIDE, PRAVASTATIN, TRAMADOL
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White