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	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm amplatzer multi-fenestrated septal occluder - cribriform was chosen for an atrial septal defect (asd) closure procedure using a 8f amplatzer trevisio intravascular delivery system.During procedure, when the device was expanding inside the body the device had a bulbous deformation.The deformed occluder was retrieved outside the patient prior to release from the delivery cable inside the patient.There was report of contacts occurred with intracardiac tissue during the occluder deployment.There were no bends or kinks been observed in the delivery sheath.A new 30mm amplatzer multi-fenestrated septal occluder - cribriform was chosen and deployed with the same delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported discharged.
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 device deformity 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 available information and without the device to analyze, the cause of the reported device deformity could not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm amplatzer multi-fenestrated septal occluder - cribriform was chosen for an atrial septal defect (asd) closure procedure using a 8f amplatzer trevisio intravascular delivery system.During procedure, when the device was expanding inside the body the device had a bulbous deformation.The deformed occluder was retrieved outside the patient prior to release from the delivery cable inside the patient.There was report of contacts occurred with intracardiac tissue during the occluder deployment.There were no bends or kinks been observed in the delivery sheath.A new 30mm amplatzer multi-fenestrated septal occluder - cribriform was chosen and deployed with the same delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported discharged.

• 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 ; 6517565400
• MDR Report Key: 22865821
• Report Number: 2135147-2025-04687
• Device Sequence Number: 7732631
• Product Code: MLV
• UDI-Device Identifier: 00811806010298
• UDI-Public: (01)00811806010298(17)280731(10)9218179
• 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
• Report Date (Section B): 10/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-MF-025
• Device Catalogue Number: 9-ASD-MF-025
• Device Lot Number: 9218179
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2023
• 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: 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM.
• Patient Sex: Male