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

Catalog Number RF400F

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Obstruction of Flow (2423)

Patient Problems Pulmonary Embolism (1498); Pain (1994); Thrombus (2101)

Event Date 05/10/2011

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.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Cava filter was somewhat tilted overlying the l3 vertebral body as well as left iliac venous stents.Subsequently on the same day, the patient presented with abdominal and back pain.A computed tomography revealed that the posterior leg of the filter had penetrated the l3 vertebra.The hook was partially embedded in the right caval wall.Five months later, there was occlusion of the inferior vena cava at the level of filter.A few attempts were made to cross the inferior vena cava occlusion from this location, but they were all unsuccessful.Multiple attempts were made to capture the filter using both forceps and snares.However, these were all unsuccessful.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter migration, occlusion of the inferior vena cava (ivc) filter and retrieval difficulties.Additionally, it can be confirmed that the patient experienced pe post deployment and thrombus above the filter.However, the relationship to the filter is unknown.Based on 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: 12/2021), (b)(4).

Event Description

It was reported through the litigation process that a vena cava filter was deployed successfully, after being diagnosed with deep vein thrombosis and pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted, migrated, occluded at the level of filter, was unable to be retrieved and struts perforated.The patient was reportedly diagnosed with thrombus above the filter and pulmonary embolism.The patient also reportedly experienced abdominal and back pain.The device has not been removed after several unsuccessful attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: G2 EXPRESS 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: 10626314
• MDR Text Key: 209765196
• Report Number: 2020394-2020-05925
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• 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: GFSK1759
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2008
• 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): Life Threatening; Other
• Patient Age: 64 YR
• Patient Weight: 125