MAUDE Adverse Event Report: AGA MEDICAL CORP AMPLATZER; MULTIFENESTRATED SEPTAL OCCLUDER "CRIBRIFORM"

Model Number 9-ASD-MF-025

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Embolism (1829)

Event Date 02/24/2014

Event Type  Injury  

Event Description

Post deployment of pfo device embolization of device occurred with its movement into the left ventricular.Attempts were made to snare the device, but were unsuccessful.Physician talked with family and decision was made to take pt to the operating room emergently for surgical removal of device.Size of pfo device and availability of pfo sizes was likely the issue in the case.

• Brand Name: AMPLATZER
• Type of Device: MULTIFENESTRATED SEPTAL OCCLUDER "CRIBRIFORM"
• Manufacturer (Section D): AGA MEDICAL CORP; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 3677450
• MDR Text Key: 19767016
• Report Number: MW5034922
• Device Sequence Number: 1
• Product Code: MLV
• 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: 02/25/2014

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
• Device Expiration Date: 10/01/2018
• Device Model Number: 9-ASD-MF-025
• Device Lot Number: 4360264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 71