MAUDE Adverse Event Report: IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Menorrhagia (4508)

Event Date 07/19/2021

Event Type  malfunction  

Event Description

Broken strut of ivc filter migrated to tricuspid valve; no associated perforation detected.Cause of death appears unrelated; incidental discovery on forensic autopsy.Mfr: probably bard.Fda safety report id # (b)(4).

• Brand Name: IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• MDR Report Key: 12210592
• MDR Text Key: 263125929
• Report Number: MW5102682
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2021
• 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 Age: 48 YR
• Patient Weight: 61