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

Catalog Number RF310F

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 08/10/2012

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately six years two months post filter deployment, computed tomography revealed some of the filter legs extended through the wall of inferior vena cava, a couple of legs were adjacent to the abdominal aorta, logged within the musculature in back and paravertebral soft tissues.The patient experienced intermittent abdominal pain and chronic low back pain with stabbing sensation.The filter problems also included migration and fracture.Subsequently a few days later, patient presented for filter retrieval.But, after numerous attempts were made, the filter could not be retrieved.There was concern for early fracture of the filter, therefore all attempts were ceased.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter detachment, filter migration and 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.

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 six years and two months later post filter deployment, it was alleged that the filter detached, migrated, struts perforated and unable to remove.The device was unable to retrieve.The patient reportedly experienced 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: 10342612
• MDR Text Key: 200961063
• Report Number: 2020394-2020-05210
• 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: 07/30/2020

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: GFPL3120
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/30/2020
• 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: LOVENOX, WARFARIN, BOTOX; LYRICA, AND BACLOFEN
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 68