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

Model Number	9-ASD-014
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 14mm amplatzer septal occluder was implanted.At the end of procedure, blood was noticed in the endotracheal breathing tube; however, once the bleeding resolved the patient was extubated successfully.Post-procedure ct scan showed the device had embolized to the abdominal aorta.On (b)(6) 2018, the occluder was snared through the femoral artery without any complications.The patient is scheduled for percutaneous closure of the asd on (b)(6) 2018.The patient is reported to be stable.
Additional Manufacturer Narrative
An event of embolization 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.
Event or Problem Description
On (b)(6) 2018, a 14mm amplatzer septal occluder was implanted.At the end of procedure, blood was noticed in the endotracheal breathing tube; however, once the bleeding resolved the patient was extubated successfully.Post-procedure ct scan showed the device had embolized to the abdominal aorta.On (b)(6) 2018, the occluder was snared through the femoral artery without any complications.The patient was scheduled for percutaneous closure of the asd on a later date.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: 8139108
• Report Number: 2135147-2018-00233
• Device Sequence Number: 13869283
• Product Code: MLV
• UDI-Device Identifier: 05415067019226
• UDI-Public: 05415067019226
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 01/04/2019

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: 07/31/2021
• Device Model Number: 9-ASD-014
• Device Catalogue Number: 9-ASD-014
• Device Lot Number: 5616978
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/18/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/04/2019
• 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: 61 YR