MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2X OR ECLIPSE; IVC FILTER

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/09/2019

Event Type  Injury  

Event Description

G2x or eclipse ivcf found to be multiply fractured and embolized with one fragment retained locally and one in the left pulmonary artery.Filter and both fragments removed.

• Brand Name: G2X OR ECLIPSE
• Type of Device: IVC FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC. ; tempe AZ
• MDR Report Key: 8239814
• MDR Text Key: 133314171
• Report Number: MW5083068
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 68