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

Model Number	9-ASD-034
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 34mm amplatzer septal occluder was implanted.After release, the device did not appear positioned correctly in the septum.The user attempted to snare and remove the device to no success.As the attempt was unsuccessful, the procedure was aborted and the patient was taken to surgery where the device was removed and the septal defect was closed.Post-operatively, the patient is reported to be stable.
Additional Manufacturer Narrative
It was reported that "the device did not appear positioned correctly in the septum" and could not be removed via snare.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 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) rev b, "do not release the device from the delivery cable if the device does not conform to its original configuration or if device position is unstable or interferes with any adjacent cardiac structure (such as svc, pv, mv, cs, ao).".
Event or Problem Description
On (b)(6) 2019, a 34mm amplatzer septal occluder was selected after sizing the defect per the ifu, measurements 32mm.The device was deployed and after release, the device did not appear positioned correctly in the septum.The user reported the left atrial disc on the posterior side of the limbus was released on the right atrial side and no residual shunt remained.As the user was concerned about device embolization, the user attempted to snare and remove the device to no success.As the attempt was unsuccessful, the procedure was aborted and the patient was taken to surgery where the device was removed and the septal defect was closed.Post-operatively, 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: 8465844
• Report Number: 2135147-2019-00089
• Device Sequence Number: 2989735
• Product Code: MLV
• UDI-Device Identifier: 05415067019356
• UDI-Public: 05415067019356
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/30/2019

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: 11/30/2020
• Device Model Number: 9-ASD-034
• Device Catalogue Number: 9-ASD-034
• Device Lot Number: 5316291
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/30/2019
• 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
• Patient Age: 62 YR