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

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

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

Event Date 07/08/2020

Event Type  Injury  

Event Description

Recovery ivcf placed in 2004 found to be multiply fractures with three arms embolized to pulmonary arteries (in retrospect this had occurred by 2010 as seen on a prior ct).Remainder of filter found to be in right atrium, new since 2013.Unclear whether migration was spontaneous or related to prior instrumentation ie catheters and pt/mother not aware of any event but pt has had multiple surgeries.Filter removed from right atrium using forceps, and fragments removed from pulmonary arteries three times.Using snare.Pt doing well and discharged next day.Fda safety report id# (b)(4).

• Brand Name: RECOVERY IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC. ; tempe AZ
• MDR Report Key: 10270164
• MDR Text Key: 198878569
• Report Number: MW5095505
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• 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: 60 YR
• Patient Weight: 98