MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-014

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020 the patient had a complex asd and underwent procedure for repair.The physician stated that device performed as expect, the device was seated well.The patient did a valsalva maneuver and then the device embolized into the aorta.The physician said he removed it with out incidence and no adverse reaction to report, hence the delay of notification.

Manufacturer Narrative

An event of device embolization was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11108592
• MDR Text Key: 225066356
• Report Number: 2135147-2020-00535
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-014
• Device Catalogue Number: 9-ASD-014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention