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

Model Number	9-ASD-010
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	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.It is unknown if the device is returning for analysis.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 patient presented with grade 4 mixed mitral regurgitation (mr) and an enlarged atrium for a mitraclip procedure.During the procedure, a steerable guide catheter (sgc) would not click into the stabilizer smoothly.It was noted that the physician required increased force to insert sgc into the stabilizer.The procedure was completed successfully.After the procedure, it was difficult to remove the sgc from the stabilizer.Troubleshooting was preformed and it required significant force to remove the sgc from the stabilizer.The final mr was grade 2.There were no adverse patient effects or clinically significant delays reported.Due to a right to left shunt, it was decided to close the iatarogenic atrial septal defect with a 10mm amplatzer septal occluder and 9f amplatzer trevisio delivery system.During implant, the occluder deformed into a cobra shape.The device was removed and replaced with another 10mm amplatzer septal occluder.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4 mixed mitral regurgitation (mr) and an enlarged atrium for a mitraclip procedure.During the procedure, a steerable guide catheter (sgc) would not click into the stabilizer smoothly.It was noted that the physician required increased force to insert sgc into the stabilizer.The procedure was completed successfully.After the procedure, it was difficult to remove the sgc from the stabilizer.Troubleshooting was preformed and it required significant force to remove the sgc from the stabilizer.The final mr was grade 2.There were no adverse patient effects or clinically significant delays reported.Due to a right to left shunt from the mitraclip procedure, it was decided to close the iatarogenic atrial septal defect with a 10mm amplatzer septal occluder and 9f amplatzer trevisio delivery system.During implant, the occluder deformed into a cobra shape.The device was removed and replaced with another 10mm amplatzer septal occluder which also experienced a cobra deformation.A third amplatzer septal occluder was then implanted without issue.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.The cause of the reported device deformity could not be conclusively determined.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: 24338868
• Report Number: 2135147-2026-00927
• Device Sequence Number: 13209153
• Product Code: MLV
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/30/2026

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-010
• Device Catalogue Number: 9-ASD-010
• Device Lot Number: 8762885
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STABILIZER
• Patient Sex: Unknown