MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER14 MILLIMETER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 00811806010113

Device Problems Positioning Problem (3009); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2021

Event Type  Injury  

Event Description

A (b)(6) year old male s/p elective closure of his atrial septal defect on (b)(6) 2021.Successful closure with a 14 millimeter amplatzer asd occluder device.Patient was discharged home the same day.Pt had post-procedure follow up echo in (b)(6) notable for echogenic structure in the interatrial septum suggestive of closure device, small shunt from left to right by colorflow doppler and positive bubble study.Follow up tee identified asd device had migrated.Taken to the cath lab and underwent successful device retrieval.Fda safety report id # (b)(4).

• Brand Name: AMPLATZER14 MILLIMETER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 11633604
• MDR Text Key: 244630691
• Report Number: MW5100630
• Device Sequence Number: 1
• Product Code: MLV
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00811806010113
• Device Catalogue Number: 9-ASD-014
• Device Lot Number: 7112165
• 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: 48 YR