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

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2019

Event Type  Injury  

Event Description

Recovery ivc filter found to be multiply fractured with 2 arms extravascular.Filter removed with forceps (tip embedded).Fragments retained.

• Brand Name: RECOVERY IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC. ; tempe AZ
• MDR Report Key: 8452702
• MDR Text Key: 140039480
• Report Number: MW5085159
• 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: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• 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: 0
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 91