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

Model Number 9-ASD-032

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

Product #1 pi main [(b)(4)] an event of device embolization 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; however, information from the field indicates, "the patient had heavy physical activity on the day of embolization and was thought to be the reason." per ifu, patients should avoid strenuous activities for a minimum of 1 month post-device implant.Strenuous activities may lead to the increased risk of adverse events.A 34 mm amplatzer atrial septal occluder was used for replacement.

Event Description

On (b)(6) 2018, a 32 mm amplatzer atrial septal occluder was implanted.On (b)(6) 2018, the device was found to have embolized and was retrieved by snare; the patient was reported stable after.Per report, the patient had heavy physical activity on the day of embolization, which was 8 days after implant.The physical activity is thought to be the reason for embolization.On (b)(6) 2018, a redo procedure was successfully completed with a 34 mm amplatzer atrial septal occluder.The patient was reported stable.

• 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: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7710693
• MDR Text Key: 114720347
• Report Number: 2135147-2018-00093
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010236
• UDI-Public: 00811806010236
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2018

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: 12/31/2022
• Device Model Number: 9-ASD-032
• Device Catalogue Number: 9-ASD-032
• Device Lot Number: 6273525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2018
• 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: 42 YR
• Patient Weight: 101