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

Catalog Number RF320J

Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problem Abdominal Pain (1685)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, two years and eleven months of post deployment, patient presented with the complaints of low back pain.An x-ray lumbar spine was performed which showed inferior vena cava filter was noted.Around, one year seventeen days later, an x-ray abdomen was performed which showed inferior vena cava filter was noted.After, eleven months and eight days, an x-ray gastrointestinal study was performed which showed inferior vena cava filter was noted at the level of l2.Around, four years and six months later, a computed tomography of abdomen and pelvis was performed which showed positive for filter fracture.A fracture of the 3 o¿clock stabilizing arm, 4 o¿clock fixation leg and 2 o¿clock fixation leg.Around, two months later, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that infrarenal inferior vena cava filter was noted.After, fourteen days, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that infrarenal inferior vena cava filter was noted.Therefore, the investigation is confirmed 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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter perforated the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: G2 FILTER SYSTEM - JUGULAR
• 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: 12717483
• MDR Text Key: 279024956
• Report Number: 2020394-2021-80794
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052578
• 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: 10/29/2021

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: RF320J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 10/29/2021
• 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: GABAPENTIN, METHOCARBAMOL, SIMVASTATIN AND ASPIRIN; HYDROCODONE-ACETAMINOPHEN AND DICLOFENAC; IBUPROFEN, FLUTICASONE, FAMOTIDINE AND LISINOPRIL
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 97