MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY IVC FILTER

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/13/2016

Event Type  Injury  

Event Description

Recovery ivcf placed in 2003 prophylactically found to be fractured, one leg broken and retained locally, two arms broken off and retained locally, and one arm (anteriorly oriented) missing altogether likely excreted in stool.Filter and all but one extravascular fragment retrieved.

• Brand Name: RECOVERY IVC FILTER
• Type of Device: IVC FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.
• MDR Report Key: 6266668
• MDR Text Key: 65531226
• Report Number: MW5067355
• Device Sequence Number: 1
• Product Code: MMX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 45 YR
• Patient Weight: 98