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

Model Number 9-ASD-010

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a 7mm amplatzer septal occluders (aso) and a 9mm aso were not implanted due to mis-sizing.A third 10mm aso was selected for implant.After releasing the device, the aso embolized from the delivery cable to the pulmonary artery.The device was retrieved by a snare and the patient was discharged and is reported to be stable.An additional procedure is planned to close the asd in the future.

Event Description

On (b)(6) 2019, a 7mm amplatzer septal occluders (aso) and a 9mm aso were not implanted due to mis-sizing.A third 10mm aso was selected for implant.After releasing the device, the aso embolized from the delivery cable to the pulmonary artery.The device was retrieved by a snare and the patient was discharged and is reported to be stable.On a future date, the asd was closed with a surgical patch and the procedure was completed with no patient consequences.

Manufacturer Narrative

An event of embolization was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.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 cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2019, a 7mm amplatzer septal occluders (aso) and a 9mm aso were not implanted due to mis-sizing.A third 10mm aso was selected for implant.After releasing the device, the aso embolized from the delivery cable to the pulmonary artery.The device was retrieved by a snare and the patient was discharged and is reported to be stable.On a future date, the asd was closed with a surgical patch and the procedure was completed with no patient consequences.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8463901
• MDR Text Key: 140289111
• Report Number: 2135147-2019-00083
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067019189
• UDI-Public: 05415067019189
• 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,Followup,Followup
• Report Date: 06/05/2019

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: 04/30/2020
• Device Model Number: 9-ASD-010
• Device Catalogue Number: 9-ASD-010
• Device Lot Number: 5095364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 03/29/2019; 05/14/2019
• Supplement Dates FDA Received: 04/24/2019; 06/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• 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