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

Model Number	9-ASD-032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	07/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: (b)(4) - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 32mm amplatzer septal occluder was selected for procedure.Initially, a 22mm amplatzer septal occluder (aso) was attempted after sizing the defect with an 18.19mm waist, but due to a floppy posterior septum and residual shunt, the device was not stable.It was uneventfully recaptured, and the 32mm amplatzer septal occluder was successfully implanted.On (b)(6) 2025, it's noted that the patient suffered a transient ischemic attack.The event lasted approximately four hours and was confirmed through a neurological exam in the emergency department, where the patient presented with acute onset hemihypesthesia.A magnetic resonance imaging scan and cranial computed tomography scan ruled out acute cerebral infarction, and symptoms completely resolved within a few hours.The patient was hospitalized for two days but experienced no other clinical signs or symptoms and did not sustain any permanent injury or disability.No intervention was performed or planned due to the event.There was no allegation of malfunction against the abbott device or procedure.The implanting physician believed the transient ischemic attack (tia) was likely device-related.The patient¿s condition resolved without sequelae as of (b)(6) 2025.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of transient ischemic attack was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported stroke 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.The patient was hospitalized for two days but experienced no other clinical signs or symptoms.The patient¿s condition resolved without sequelae.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.

• 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 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22690004
• Report Number: 2135147-2025-04290
• Device Sequence Number: 18403371
• Product Code: MLV
• UDI-Device Identifier: 00811806010236
• UDI-Public: (01)00811806010236(17)291231(10)10670117
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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 Model Number: 9-ASD-032
• Device Catalogue Number: 9-ASD-032
• Device Lot Number: 10670117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2025
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Male
• Patient Weight: 148 KG