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

Catalog Number RF400F

Device Problem Obstruction of Flow (2423)

Patient Problems Edema (1820); Occlusion (1984); Pain (1994)

Event Date 08/14/2015

Event Type  Injury  

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.Medical record review: a vena cava filter was deployed for a preoperative diagnosis of deep vein thrombosis and gastric bypass surgery.The deployed filter was successfully placed infrarenal via the right common femoral vein after an attempted placement in the right common iliac vein.Attempted placement was terminated due to the filter coiling up several times in the right groin due to body habitus.Inferior venacavogram performed during filter deployment revealed the inferior vena cava diameter to be 22 mm.Patient tolerated the successful placement procedure without complications.Approximately six years post deployment, a venogram was performed indicating patency of the left femoral and popliteal veins, normal flow in to the left iliac veins with an occlusion in the ivc at the level of the filter with extension into the left common iliac vein.Approximate sixteen days later, the patient presented for filter removal via the right internal jugular vein.Venograms indicated the ivc to be occluded, right iliac and right common iliac veins demonstrated webs and chronic occlusive disease.The filter was snared with a gooseneck snare and spectranetics glidelite laser sheath.Ivc filter removed with assisted endovascular laser.Right common iliac vein was stenosed and dilated with a mustang balloon.Filter was inspected and found to be intact.Venogram demonstrated a small amount pericaval extravasation which appeared not clinically significant.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Approximately six years post deployment, a venogram indicated an occlusion in the ivc at the level of the filter with extension into the left common iliac vein.Therefore, the investigation is confirmed for occlusion of the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: precautions: the safety and effectiveness of this device has not been established for morbidly obese patients.Open abdominal procedures such as bariatric surgery may affect the integrity and stability of the filter 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: 10/2011); (manufacturing date: 10/2008).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure.At some time post filter deployment, it was alleged that the patient experienced deep vein thrombosis, vein occlusion with extensive fibrous web development, pelvic venous obstruction, and complex laser assisted removal of indwelling ivc filter with angioplasty.Furthermore, it was alleged that the patient also experienced a vein stenting procedure, pain, edema, and other continuing sequelae.The device was removed percutaneously.The current status of the patient is unknown.

• Brand Name: G2 EXPRESS FILTER SYST - FEM
• 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: 8048288
• MDR Text Key: 126503042
• Report Number: 2020394-2018-01993
• 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: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF400F
• Device Lot Number: GFSI2315
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2018
• 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): Other
• Patient Age: 53 YR
• Patient Weight: 173