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

Catalog Number RF400J

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problem Abdominal Pain (1685)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2013).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with left lower extremity deep vein thrombosis and unexplained renal failure.Around six years and six months post filter deployment, a computed tomography (ct) abdomen and pelvis without oral or intravenous contrast revealed that the filter tilted, filter strut twisted and struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and 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, five years eight months of post-deployment, the patient experienced chest pain and shortness of breath.On the same day, a computed tomography (ct) chest with intravenous contrast showed that there was no evidence of pulmonary embolus.Around ten months and sixteen days later, the patient experienced acute onset of right flank pain and right upper quadrant abdominal pain.On the same day, a computed tomography (ct) abdomen and pelvis without oral or intravenous contrast showed that there was an infrarenal inferior vena cava filter, noted to be in an abnormal but stable position.Several legs of the filter were projected beyond the wall of the cava.This was not an uncommon occurrence.However, one of the legs projected against or minimally into the aorta.Additional leg projected posterior to the aorta, against the posterior wall.There was no evidence for retroperitoneal hemorrhage.Around, eleven months and twenty-one days later, a computed tomography (ct) abdomen and pelvis without oral or intravenous contrast showed that there was an infrarenal inferior vena cava filter.The apex pointed cranially and was tilted, abutted the right lateral inferior vena cava wall.The struts were intact and all the struts were seen pierced through the inferior vena cava walls.A single strut was significantly twisted and appeared to be pierced through the wall of the abdominal aorta superiorly.Therefore, the investigation is confirmed for the material deformation, perforation of the inferior vena cava (ivc) and filter tilt.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 01/2013), g4.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 left lower extremity deep vein thrombosis and unexplained renal failure.Around six years and six months post filter deployment, a computed tomography (ct) abdomen and pelvis without oral or intravenous contrast revealed that the filter tilted, filter strut twisted and struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.

• Brand Name: G2 X FILTER SYSTEM - JUGULAR
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10820950
• MDR Text Key: 215933033
• Report Number: 2020394-2020-20406
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K082305
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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: RF400J
• Device Lot Number: GFTL2136
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PEPCID AND CARAFATE; PEPCID AND CARAFATE
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 118