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

Model Number 9-ASD-018

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Embolism (1829)

Event Date 01/04/2020

Event Type  Injury  

Manufacturer Narrative

An event of embolization of the 18mm occluder with subsequent implant of a larger, 24mm device 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.Based on the information received, the device was potentially undersized; however, the extent to which this contributed to the subsequent embolization could not be conclusively determined.Information from the field indicated that the device was removed 1 month after embolization.Please note, per the instructions for use artmt100116885 rev.A, "embolized devices must be removed because they may cause patient harm.Embolized devices should not be withdrawn through intracardiac structures unless they have been collapsed within a sheath.".

Event Description

On (b)(6) 2020, an 18 mm amplatzer septal occluder was implanted.The following day, the device embolized to the left atrium.The patient did not present any symptoms.On (b)(6), the physician removed the embolized device percutaneously.On (b)(6), a 24mm amplatzer septal occluder was successfully implanted.The patient is currently stable.

• 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: 9783081
• MDR Text Key: 183945610
• Report Number: 2135147-2020-00087
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010151
• UDI-Public: 00811806010151
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2020

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 Expiration Date: 12/31/2023
• Device Model Number: 9-ASD-018
• Device Catalogue Number: 9-ASD-018
• Device Lot Number: 6837013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR