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

Catalog Number RF320J

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

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 the filter migrated, tilted and struts perforated into organs.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.

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 the filter migrated, tilted and struts perforated into organs.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: a 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 nine years and nine months later, computed tomography (ct) revealed that an inferior vena cava filter in appropriate position inferior to the renal veins.No inferior vena cava filter tilt was noted.No strut fracture was noted.There was an anterior strut perforating approximately 3 mm beyond the anterior inferior vena cava and contacting the duodenum.There was an anteromedial strut perforating approximately 4 mm.There was a medial strut perforating approximately 4 mm extending between the posterior aorta and anterior vertebral body.There were three posterolateral struts perforating approximately 4 to 5 mm along the lateral aspect of the vertebral body.There was an anterolateral strut perforating 3 mm and contacting the duodenum.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava (ivc).However, the investigation is inconclusive for alleged filter migration and filter tilt.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.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.

• 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
• MDR Report Key: 10973964
• MDR Text Key: 220425166
• Report Number: 2020394-2020-06482
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K052578
• 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: 01/06/2021

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: 11/12/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLONIDINE, MIDRIN, ADVIL; CLONIDINE, MIDRIN, ADVIL; INDERAL, PREMARIN, SYNTHROID; INDERAL, PREMARIN, SYNTHROID; CLONIDINE, MIDRIN, ADVIL; INDERAL, PREMARIN, SYNTHROID
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 96