MAUDE Adverse Event Report: ABBOTT LABORATORIES AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number 9-ASD-016

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Date 01/15/2019

Event Type  Injury  

Event Description

Embolization of amplatzer 16mm septal occluder.Retrieved from abdominal aorta.Dates of use: (b)(6) 2019.Diagnosis or reason for use: patent asd.Event abated after use stopped or reduced? yes.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8320593
• MDR Text Key: 135880417
• Report Number: MW5083840
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): Y
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-016
• Device Lot Number: 6441773
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 75