MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-ASD-015

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problems Embolism (1829); No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

An event of migration 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2018, a 15mm amplazer septal occluder (aso) was selected for implant.The device was delivered and deployed, and following a tug test to confirm stability of device in defect, the aso was released from the delivery cable.Shortly after releasing the aso from the delivery cable, the device embolized into the left atrium and to the mitral valve.The device was surgically removed and the defect was surgically closed without additional complications and the patient was reported to be stable.The physician indicated that the aso was manipulated more than necessary during the tug test, resulting in device embolization after being released from delivery cable.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7400511
• MDR Text Key: 104531718
• Report Number: 2135147-2018-00040
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 9-ASD-015
• Device Catalogue Number: 9-ASD-015
• Device Lot Number: 5325865
• Other Device ID Number: 00811806010120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 21