MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2X FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number RF400F

Device Problems Patient-Device Incompatibility (2682); Extrusion (2934)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Medical record review: a vena cava filter was placed infrarenal status post motor vehicle accident with traumatic brain injury and upper extremity and left posterior tibial vein deep vein thrombosis.Approximately five months post filter deployment, a bilateral upper extremity venous doppler ultrasound was compared to imaging six weeks earlier with patient on coumadin.It revealed no evidence of upper extremity deep vein thrombosis bilaterally.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.There was no specific deficiency alleged in the provided medical records.Therefore, the investigation is inconclusive for perforation as no objective evidence has been provided to confirm any alleged deficiency with the filter.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.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 and in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that filter limbs perforated into organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The current patient status is unknown.

Manufacturer Narrative

Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately eight years and one month later post filter deployment, a computed tomography of abdomen and pelvis was performed for inferior vena cava filter evaluation.The study showed that the tip of the inferior vena cava filter was in normal position immediately inferior to the lowest renal vein and there was no filter tilt.Also, the apex of the filter was not touched the wall of the inferior vena cava and there was no strut fracture.The study also showed that a left posterior strut extended greater than 3 mm past the wall of the cava and there was a fat plane between the tip of the strut and the cava.The tip of this strut abutted the right aortic surface but does not extend into the aorta and there was no adjacent fluid or mass.The left strut posterior to this also appeared to extend past the confines of the inferior vena cava wall into the prevertebral fat without touching the spine or other structures.Also, the remaining struts were within 3 mm of the wall of the inferior vena cava and there was no evident fat plane between the struts and the cava.The computed tomography study was reviewed, and the study demonstrated that an inferior vena cava filter was noted and there was no tilt of the filter as well as the apex of inferior vena cava filter was within the center of the inferior vena cava.Also, there was perforation of the primary struts and secondary struts beyond the wall of the inferior vena cava, and these perforated on 3 mm in size from the termination point inferior vena cava wall.Also, a single medial strut perforated medially, and its tip abutted the aorta however, no perforation within the aorta was identified.There was also perforation of struts about the anterior aspect of the inferior vena cava filter and one of these primary struts perforated into the small bowel.Additionally, the remainder the struts perforated into either the retroperitoneal fat or the mesentery.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava.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.H11:section a through f - the information provided by bd 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 bd.

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; in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter struts perforated into the organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The current patient status is unknown.

• Brand Name: G2X 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: 7627966
• MDR Text Key: 112422308
• Report Number: 2020394-2018-00958
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082305
• 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,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF400F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2022
• 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: COUMADIN
• Patient Age: 51 YR
• Patient Sex: Male