MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-ASD-028
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2022, a 28mm amplatzer septal occluder was implanted into the patient using a 12f amplatzer trevisio intravascular delivery system.During the procedure, the patient remained hemodynamically stable.There was no clinically significant delay in procedure and no adverse patient effects.On (b)(6) 2022, the patient presented to the hospital with shortness of breath.It was discovered that the device was still in place in the atrial septum, but there was a residual shunt.The device was then removed via catheter snare successfully.The defect was remeasured with intracardiac echocardiography (ice) and a 34mm sizing balloon and 24mm sizing balloon.A 30mm amplatzer septal occluder (lot 6693761) was attempted to be implanted, but it was too small and removed from the patient.A 34mm amplatzer septal occluder (lot 7343171) was attempted to be implanted, but it was two small and was removed from the patient.The patient remained hemodynamically stable throughout the procedure.The patient was referred for surgical closure of the atrial septal defect.The patient was reported to be stable and has since been discharged.
Additional Manufacturer Narrative
An event of residual shunt was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2022, a 28mm amplatzer septal occluder was implanted into the patient using a 12f amplatzer trevisio intravascular delivery system.During the procedure, the patient remained hemodynamically stable.There was no clinically significant delay in procedure and no adverse patient effects.On 05 august 2022, the patient presented to the hospital with shortness of breath.It was discovered that the device was still in place in the atrial septum, but there was a residual shunt.The device was then removed via catheter snare successfully.The defect was remeasured with intracardiac echocardiography (ice) and a 34mm sizing balloon and 24mm sizing balloon.A 30mm amplatzer septal occluder (lot 6693761) was attempted to be implanted, but it was too small and removed from the patient.A 34mm amplatzer septal occluder (lot 7343171) was attempted to be implanted, but it was two small and was removed from the patient.The patient remained hemodynamically stable throughout the procedure.The patient was referred for surgical closure of the atrial septal defect.The patient was reported to be stable and has since been discharged.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15349104
• Report Number: 2135147-2022-00989
• Device Sequence Number: 5206473
• Product Code: MLV
• UDI-Device Identifier: 05415067019325
• UDI-Public: 05415067019325
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: 9-ASD-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 7724979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TREVISIO DELIVERY SYSTEM, 9-ATV12F45/80
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 28 YR
• Patient Sex: Female