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

Model Number	9-ASD-036
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Embolism (1829); Ventricle, Abnormality Of (2078); No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of device embolization and explant of the device was reported.A more comprehensive assessment could not be performed as the device 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.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
On (b)(6) 2020 a 34mm asd device was prepped and delivered to the defect.The patient has a baseline rhythm of sinus rhythm.Significant residual shunting was noted on an echo and the 34mm device was not released due to residual shunting by echo.A 36mm asd device was prepped and delivered to the defect.The echo showed no residual shunt and was stable.The device was released and appeared to remain in a stable position on tee.Approximately 3 minutes later the patient experienced ventricular ectopy and tee confirmed that the device had embolized into the right atrium.The patient returned to sinus rhythm soon after.The 36mm device was retrieved in the or and the defect was closed surgically with a patch.There was no clinically significant delay.The patient remained stable through out the entire procedure.

• 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: 10469208
• Report Number: 2135147-2020-00381
• Device Sequence Number: 16763158
• Product Code: MLV
• UDI-Device Identifier: 00811806010250
• UDI-Public: 00811806010250
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2020

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: 06/30/2024
• Device Model Number: 9-ASD-036
• Device Catalogue Number: 9-ASD-036
• Device Lot Number: 7092612
• 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: 08/02/2020
• Initial Report FDA Received Date: 08/28/2020
• 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: 38 YR