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

Model Number	9-ASD-024
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 26 mm amplatzer atrial septal occluder (aso) was selected to close an atrial septal defect with a pediatric patient.The 26 mm amplatzer aso was found to be too large so a 24 mm amplatzer aso was implanted.There was concern for the 24 mm amplatzer aso device on whether or not it was seated well and could cause possible erosion.On (b)(6) 2018, the patient went to the operating room (or) to have the device surgically removed and defect closed.The surgery was successful and the patient is reported as stable.The physician states that the 24 mm amplatzer aso device was removed due to the concern of the size of the device required to close the defect in relation to the small size of the patient.
Additional Manufacturer Narrative
Event description: additional information was requested, but not provided by the physician or hospital.An event of user concern regarding the device being seated well 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.The physician stated that the concern was regarding "the size of the device required to close the defect in relation to the small size of the patient.".
Event or Problem Description
On (b)(6) 2018, a 26mm amplatzer atrial septal occluder (aso) was selected to close an atrial septal defect with a pediatric patient.The 26mm amplatzer aso was found to be too large so a 24mm amplatzer aso was implanted.There was concern for the 24mm amplatzer aso device on whether or not it was seated well and could cause possible erosion.On (b)(6) 2018, the patient went to the or to have the device surgically removed and defect closed.The surgery was successful and the patient is reported as stable.The physician states that the 24mm amplatzer aso device was removed due to the concern of the size of the device required to close the defect in relation to the small size of the patient.Operation reports were requested, but not provided by the physician or hospital.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7699686
• Report Number: 2135147-2018-00091
• Device Sequence Number: 996130
• Product Code: MLV
• UDI-Device Identifier: 05415067019301
• UDI-Public: 05415067019301
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 9-ASD-024
• Device Catalogue Number: 9-ASD-024
• Device Lot Number: 5112424
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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
• Patient Age: 3 YR
• Patient Weight: 14