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

Model Number	9-ASD-026
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
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 an unknown date, an 18mm amplatzer septal occluder was implanted.Following the procedure, on (b)(6) 2019, the device was reported to have embolized.On (b)(6) 2019, the device was removed from the patient percutaneously by snaring and re-sheathing.The defect was balloon-sized to 18mm using a 30mm pts sizing balloon (lot number: unknown) and the physician attempted closure with a 22mm amplatzer septal occluder (lot number: 6821072) and 26mm amplatzer septal occluder (lot number: 5562243).Both devices were reported to be mis-sized.Of note, the 26mm amplatzer septal occluder was impinging on the mitral valve.The physician elected to abandoned the procedure and surgical closure is planned for a future time.
Additional Manufacturer Narrative
Additional information: supplemental report needed to address analysis.Supplemental report needed for implant date and anatomical difficulties.Investigation will not be performed as the event did not indicate a malfunction.Correction: upon review, the septal occluder should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.
Event or Problem Description
On (b)(6) 2019, an 18mm amplatzer septal occluder was implanted.Following the procedure, the device was reported to have embolized.On (b)(6) 2019, the device was removed from the patient percutaneously by snaring and re-sheathing.The defect was balloon-sized to 18mm using a 30mm pts sizing balloon (lot number: unknown) and the physician attempted closure with a 22mm amplatzer septal occluder (lot number: 6821072) and 26mm amplatzer septal occluder (lot number: 5562243).Both devices were reported to be mis-sized.Of note, the 26mm amplatzer septal occluder was impinging on the mitral valve.Additionally, the patient had multiple asds and challenging anatomical features which caused the mis-sizing.The physician elected to abandoned the procedure and surgical closure is planned for a future time.

• 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: 8697308
• Report Number: 2135147-2019-00160
• Device Sequence Number: 2473129
• Product Code: MLV
• UDI-Device Identifier: 05415067019318
• UDI-Public: 05415067019318
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

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: 06/30/2021
• Device Model Number: 9-ASD-026
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 5562243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/12/2019
• 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