MAUDE Adverse Event Report: MEDTRONIC / EV3, INC. MEDTRONIC ABRE STENT; STENT, ILIAC VEIN

Lot Number B227177

Device Problems Entrapment of Device (1212); Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/31/2022

Event Type  Injury  

Event Description

Migration of stent into the atrium.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC ABRE STENT
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): MEDTRONIC / EV3, INC.
• MDR Report Key: 13541728
• MDR Text Key: 285703779
• Report Number: MW5107451
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: B227177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male