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

Catalog Number RF310F

Device Problems Detachment of Device or Device Component (2907); Extrusion (2934); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 07/07/2012

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.This is the only event reported to date for this lot number and failure mode.Medical records review: the patient with deep vein thrombosis and thrombocytopenia had a vena cava filter successfully deployed at the body of l2.Approximately two years and three months post filter deployment, a chest x-ray revealed a linear metallic density within the right subhilar region with the appearance of a displaced filter prong.Approximately two years and four months post filter deployment, a chest x-ray revealed better visualization of the known medial right lung base metallic density likely to be a fragment of the filter.Investigation summary: the device was not returned for evaluation and images were not provided for review.However, medical records were provided and reviewed.Based on the provided medical records, the investigation is confirmed for a detached filter limb.The investigation is inconclusive for the alleged perforation as provided medical records provide no information relating to this deficiency.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.Perforation or other acute or chronic damage of the ivc wall procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

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 limbs detached, perforated and embolized to the right lung.Reportedly, no attempt has been made to retrieve the filter or the detached limbs.The status of the patient is unknown.

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.Approximately two years and three months post filter deployment, chest x-ray revealed that there was a linear metallic density across the right sub hilar region with a history of an inferior vena cava filter, that had the appearance of a displaced filter prong.Eventually a month later, chest x-ray revealed that there was known linear metallic foreign body that overlay the medial right lung base, which may represent an inferior vena cava filter fragment.Therefore, the investigation is confirmed for filter limb detachment.However, the investigation is inconclusive for perforation of the inferior vena cava (ivc).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.(expiry date: 11/2012).

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 limbs detached, perforated and embolized to the right lung.The device has not been removed and there were no reported attempts made to retrieve the filter.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
• MDR Report Key: 7306799
• MDR Text Key: 101484531
• Report Number: 2020394-2018-00175
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K062887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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 Expiration Date: 11/30/2012
• Device Catalogue Number: RF310F
• Device Lot Number: GFTJ1625
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/01/2018
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALPRAZOLAM, XANAX, MIRALAX, CARAFATE AND CLARITIN; ATIVAN AND PERCOCET; LIPITOR, ASPIRIN AND LEVOTHYROXINE SODIUM; ORETIC, ZYRTEC, NEURONTIN, DRISDOL AND VALIUM; SYNTHROID, VICODIN, FOLIC ACID AND PRILOSEC; TYLENOL, PROTONIX, WELLBUTRIN, DULCOLAX AND COLACE; ZOFRAN, LEVAQUIN, HEPARIN, TORADOL AND LASIX; ZYLOPRIM, SILVADENE, LOVENOX, CIPRO AND LIPODRENE
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 97