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

Model Number 9-ASD-016

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 16mm amplatzer septal occluder (aso) was implanted in a patient with adequate rims.The aso was well sized and appeared very stable as confirmed by push/pull test and via tee.The patient had a chest x-ray while in recovery that showed the aso in the correct position.The next day, the discharge chest x-ray showed the aso to have embolized to the aorta.The patient was referred for surgery for retrieval of the aso and surgical closure of the defect.The patient is reported to be recovering.

Manufacturer Narrative

An event of embolization of the 16mm amplatzer septal occluder to the aorta was reported.The returned 16mm amplatzer septal occluder met all functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.Based on information from the physician the angle through the internal jugular made implantation difficult and without a balloon sizing, the physician believed the 16mm amplatzer occluder was undersized.

Event Description

On (b)(6) 2018, a 16mm amplatzer septal occluder (aso) was implanted in a patient with adequate septal rims.The aso was well sized and appeared very stable as confirmed by push/pull test and via tee.The patient had a chest x-ray while in recovery that showed the aso in the correct position.The next day, the discharge chest x-ray showed the aso to have embolized to the aorta.The patient was referred for surgery for retrieval of the aso and surgical closure of the defect.The patient is reported to be recovering.

• 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: 7652351
• MDR Text Key: 112840163
• Report Number: 2135147-2018-00085
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010137
• UDI-Public: 00811806010137
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 08/13/2018

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: 04/30/2019
• Device Model Number: 9-ASD-016
• Device Catalogue Number: 9-ASD-016
• Device Lot Number: 4629803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2014
• 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