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

Model Number	9-ASD-015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Stroke/CVA (1770); Endocarditis (1834); Coma (2417); Movement Disorder (4412)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 15mm amplatzer septal occluder was implanted in the patient.On (b)(6) 2025, the patient required emergency hospitalization for endocarditis.The patient is still in coma, in resuscitation in critical stage.The occluder is still implanted in the patient.The patient is still hospitalized and reported stable.
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.
Additional Manufacturer Narrative
An event of patient effects patient-device incompatibility was reported.A returned device assessment could not be performed as the device remains implanted and 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.There were no complaints associated with any other devices from the lot.The coma and prolonged hospitalization is likely a cascading effect of patient-device incompatibility.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that an on (b)(6) 2025, an 11-year-old female with an atrial septal defect (asd) and no other past medical history underwent transcatheter asd closure using a 15 mm amplatzer septal occluder (aso).The patient had a follow-up echocardiogram in mid-september that demonstrated that the aso was well-positioned with no evidence of any anomalies.Subsequently, the patient reported that she took a swim in a lake and soon after had itching.On (b)(6) the patient presented with endocarditis requiring emergency hospitalization and went into a coma.The patient was found to have staphylococcus aureus bacterial endocarditis and was successfully treated with intravenous antibiotics.The patient responded well to the antibiotic treatment and currently is awake.However, the patient had a stroke due to presumed septic emboli, that resulted in bilateral lower extremity paralysis and dysphagia.The patient is currently in a rehabilitation center and is gradually improving.Ultimately, the patient will likely undergo open heart surgery to explant the device and repair the asd, however this has not been scheduled.

• 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: 23337192
• Report Number: 2135147-2025-05990
• Device Sequence Number: 21199862
• Product Code: MLV
• UDI-Device Identifier: 00811806010120
• UDI-Public: (01)00811806010120(17)290630(10)10449579
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-015
• Device Catalogue Number: 9-ASD-015
• Device Lot Number: 10449579
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2024
• 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: Hospitalization
• Patient Age: 11 YR
• Patient Sex: Unknown