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

Model Number	9-ASD-018
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271); Syncope/Fainting (4411); Unspecified Tissue Injury (4559)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, an 18mm amplatzer septal occluder was implanted.The implantation procedure was uneventful, and post-implantation transesophageal echocardiogram (tee) showed no signs of compression.On (b)(6) 2025, the patient lost conciousnouss in public and was transported to the hospital.Pericardial effusion was observed that was leading to cardiac tamponade.The patient underwent emergent surgical intervention as device erosion was observed.The device was explanted and the septal defect was surgically repaired.
Additional Manufacturer Narrative
The device is not returning 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 tissue erosion, pericardial effusion, cardiac tamponade, syncope, and hospitalization was reported.A returned device assessment could not be performed as the device 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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported pericardial effusion, cardiac tamponade and tissue erosion could not be conclusively determined.The reported hospitalization and subsequent surgical intervention were due to specific circumstances: the patient was admitted for pericardiocentesis, device removal, and surgical repair of the atrial septal defect.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes added: h6 health effect - impact code: 4641 added.
Additional Manufacturer Narrative
An event of tissue erosion, pericardial effusion, cardiac tamponade, syncope, and hospitalization was reported.A returned device assessment could not be performed as the device 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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information and without the device to analyze, the exact cause of the reported pericardial effusion, cardiac tamponade, and tissue erosion could not be conclusively determined.It is possible that the pericardial effusion and cardiac tamponade were results related to tissue erosion; however, this cannot be confirmed.Per the instructions for use (ifu), ¿absence of the anterior superior (aortic) rim and device oversizing may be related to the causation of erosion due to the increased likelihood of device-tissue contact in the dynamic anatomic area at highest risk for erosion.¿ in this case, the presence of a white mark on the aortic wall suggests a scenario consistent with erosion, although this cannot be confirmed without further analysis.The reported hospitalization and subsequent surgical intervention were due to specific circumstances: the patient was admitted for pericardiocentesis, device removal, and surgical repair of the atrial septal defect.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Correction: h11 - additional mfg narrative updated.

• 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: 22080818
• Report Number: 2135147-2025-02767
• Device Sequence Number: 8703471
• Product Code: MLV
• UDI-Device Identifier: 00811806010151
• UDI-Public: (01)00811806010151(17)271031(10)8776337
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 07/29/2025

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-018
• Device Catalogue Number: 9-ASD-018
• Device Lot Number: 8776337
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 07/22/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/18/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2022
• 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; Required Intervention
• Patient Sex: Unknown