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

Model Number	9-ASD-009
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 9mm amplatzer septal occluder (aso), 10mm aso and a 14mm aso were selected to close a pseudoaneurysm (psa) in a patient diagnosed with an aortic dissection along the entire length of the aorta and an ascending aortic pseudoaneurysm.After attempting to implant all three devices, the asos were reported to have dislocated.After the 14mm aso dislocated, the device was exchanged for the original 9mm aso.Three minutes following implant, the device embolized to the false lumen of the descending aorta with no impact to the patient status.No immediate attempt was made to retrieve the embolized aso since there was no impact on aortic flow.The patient remained stable throughout the procedure and was transferred to surgery to repair the psa, aortic dissection and possible removal of the aso.The patient is reported to be stable.
Additional Manufacturer Narrative
An event of embolization was reported.The results of the investigation are inconclusive since the device remains implanted 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 cause of the reported incident could not be conclusively determined.Please note per the instructions for use, (b)(4) version a "embolized devices must be removed as they may disrupt critical cardiac functions.Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within the sheath." also "the amplatzer¿ septal occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defects (asd) in secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration.".
Event or Problem Description
On (b(6) 2019, a 9mm amplatzer septal occluder (aso), 10mm aso and a 14mm aso were selected to close a pseudoaneurysm (psa) in a patient diagnosed with an aortic dissection along the entire length of the aorta and an ascending aortic pseudoaneurysm.After attempting to implant all three devices, the asos were reported to have dislocated.After the 14mm aso dislocated, the device was exchanged for the original 9mm aso.Three minutes following implant, the device embolized to the false lumen of the descending aorta with no impact to the patient status.No immediate attempt was made to retrieve the embolized aso since there was no impact on aortic flow.The patient remained stable throughout the procedure and was transferred to surgery to repair the psa, aortic dissection and possible removal of the aso.The patient is reported to be stable.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8677043
• Report Number: 2135147-2019-00150
• Device Sequence Number: 11295064
• Product Code: MLV
• UDI-Device Identifier: 05415067019172
• UDI-Public: 05415067019172
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 9-ASD-009
• Device Catalogue Number: 9-ASD-009
• Device Lot Number: 5341010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention