MAUDE Adverse Event Report: CR BARD INC. G2; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/29/2017

Event Type  malfunction  

Event Description

Inferior vena cava filter placed in patient 10 years ago.Patient has history of pulmonary embolus/deep vein thrombosis with inferior vena cava filter.Found to have metal emboli from inferior vena cava filter to right ventricle (of heart) and right upper lobe (of lung).Surgeons removed filter and retrieved fragments in right ventricle (of heart).Inferior vena cava filter removed in vascular interventional radiology and fragment in right ventricle (of heart) removed in open heart surgery.Manufacturer response for bard g2 ivc, (brand not provided) (per site reporter).Failed equipment maintained by (b)(6) legal team.Bard made aware of the issue.

• Brand Name: G2
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CR BARD INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7302388
• MDR Text Key: 101150227
• Report Number: 7302388
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other