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

Model Number 9-ASD-024

Device Problem Unintended Movement (3026)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, a 24mm amplatzer septal occluder was implanted.The patient was experiencing multiple episodes of nausea and vomiting post procedure.On (b)(6) 2019, a follow-up echocardiogram was performed and noted the device has embolized.The patient was taken to the cath lab and the device was successfully retrieved without complications.A 28mm amplatzer septal occluder was successfully implanted.On (b)(6) 2020, a follow-up echocardiogram was performed and the device was in it's desired location.The patient was reported to be in stable condition.

Manufacturer Narrative

An event of embolization of a 24mm amplatzer septal occluder (aso) before being replaced by a 28mm aso was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The upsizing to a larger device following embolization is possible evidence of undersizing; however, 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
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9580401
• MDR Text Key: 178352655
• Report Number: 2135147-2020-00016
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010199
• UDI-Public: 00811806010199
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-024
• Device Catalogue Number: 9-ASD-024
• Device Lot Number: 7063451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention