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

Model Number	9-ASD-034
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event of deformation could not be confirmed.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.
Event or Problem Description
On (b)(6) 2018, a patient presented with an atrial septal defect (asd) with an absence of an anterior aortic rim.After sizing the defect, a 32mm amplatzer septal occluder (aso) was selected for implant.The device was inserted and positioned, but pulled through the defect and was deemed too small.The device was replaced with a 34mm aso.Both the left atrial disc and right atrial disc were deployed, but the ice images revealed the anterior margin of the device adjacent to the aortic valve did not appear fully expanded.A push-pull test was performed and the device pulled through the defect.The physician decided to abort the procedure and obtain cardiac surgery consult due to the risk of erosion.

• 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: 8428649
• Report Number: 2135147-2019-00079
• Device Sequence Number: 3026395
• Product Code: MLV
• UDI-Device Identifier: 00811806010243
• UDI-Public: 00811806010243
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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: 10/31/2023
• Device Model Number: 9-ASD-034
• Device Catalogue Number: 9-ASD-034
• Device Lot Number: 6737227
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/18/2019
• 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: Required Intervention
• Patient Age: 52 YR