MAUDE Adverse Event Report: ABBOTT MEDICAL Amplatzer Multi-Fenestrated Septal Occluder - Cribriform; Transcatheter Septal Occluder

Model Number	9-ASD-MF-025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm amplatzer cribriform was chosen for implant using an unknown delivery system.During the procedure, the device was introduced and advanced for placement, and after deployment, an increase in the patient¿s left atrial (la) pressure was observed, which was sustained.The patient did not develop any clinical symptoms, and no clinical diagnosis was made in relation to the pressure increase.The device was not completely released and was removed prior to release from the delivery cable.Therefore, the physician chose to stop the procedure for safety reasons, and no other device was attempted.No intervention or treatment was required.The increase in la pressure was described as a clinically recognized phenomenon that may occur after device placement due to occlusion of the shunt, which can increase load on the left atrium and right heart, and cannot be determined in advance.No allegations were made against any abbott device, and the event was not attributed to device performance.

• Brand Name: Amplatzer Multi-Fenestrated Septal Occluder - Cribriform
• Common Device Name: Transcatheter Septal Occluder
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): Abbott Medical Reg# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 25679611
• Report Number: 2135147-2026-04541
• Device Sequence Number: 9709267
• Product Code: MLV
• UDI-Device Identifier: 00811806010298
• UDI-Public: (01)00811806010298(17)300430(10)10864746
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 10/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-MF-025
• Device Catalogue Number: 9-ASD-MF-025
• Device Lot Number: 10864746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 07/21/2026; 09/28/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 08/04/2026; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• 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
• Patient Sex: Unknown